Looking For Novel New Drug Approvals Of 2015? Here's The List...

Add as your preferred news source on Google

Add Now

The process of drug development is challenging. Some drugs pass the FDA muster easily, while some face a host of hurdles before getting the official stamp of approval.

The FDA approved 45 novel new drugs in 2015 compared to 41 in 2014 and 27 in 2013. The number of novel new drug approvals from 2005 through 2014 averaged nearly 27 per year.

As we enter the New Year, it's time to take a look at the new molecular entities and biologics that were green-lighted in 2015.

DECEMBER

Zurampic

Approved on December 22, 2015, Zurampic is indicated for the treatment of high blood uric acid levels associated with gout in combination with a xanthine oxidase inhibitor, a class of drug, which is already approved to treat gout.

Gout is a painful form of arthritis characterized by too much uric acid in the body. Historically known as the "disease of kings" due to its association with rich diet and alcohol, the prevalence and incidence of gout has been on the rise. The global gout therapy market was worth $0.8 billion in 2014, according to Statista Inc. More than 8.3 million people in the United States are said to have gout.

Zurampic, manufactured by AstraZeneca Plc (AZN), works by helping the kidney excrete uric acid, and this done by inhibiting the function of transporter proteins involved in uric acid reabsorption in the kidney.

Known chemically as lesinurad, Zurampic has a boxed warning about the risk for acute kidney failure that is more common if used alone, or in a higher than normal dose.

AstraZeneca has been asked to conduct a post marketing study to further evaluate the renal and cardiovascular safety of Zurampic.

Uptravi

Approved on December 21, 2015, Uptravi is indicated for treating adults with pulmonary arterial hypertension.

Pulmonary arterial hypertension, or PAH in short, is a rare disorder characterised by high blood pressure in the arteries that go from the heart to the lungs.

Uptravi, which has the designation of orphan drug, acts by relaxing muscles in the walls of blood vessels to dilate blood vessels and decrease the elevated pressure in the vessels supplying blood to the lungs.

Uptravi, known chemically as selexipag, is marketed by Actelion Ltd., and will directly compete with United Therapeutics' Orenitram. Some of the other approved drugs for PAH are its very own Opsumit, United Therapeutics' Remodulin and Tyvaso, and Bayer's Adempas.

Analysts expect Uptravi to achieve worldwide peak sales of more than a billion.

Bridion

Approved on December 15, 2015, Merck & Co. Inc.'s (MRK) Bridion injection is indicated to reverse the effects of certain *neuromuscular blocking drugs like Rocuronium or Vecuronium, which are used as part of general anaesthesia during surgical procedures, and restore spontaneous breathing after surgery.

*Neuromuscular blocking drugs are used to paralyze the vocal cords when patients require an artificial airway or breathing tube for surgery, a process called tracheal intubation, ensure patient immobility and improve surgical exposure.

In the U.S., Bridion will have to compete with Flamel Technologies' Bloxiverz, which was approved by the FDA in 2013, and Fresenius Kabi's Neostigmine Methylsulfate Injection, which was approved in January of this year.

Bridion was approved by the European Commission in August 2008, and is currently available in more than 50 countries outside the U.S. Sales of Bridion were $262 million in the nine months of 2015, an increase of 7% compared with the year-ago period.

Alecensa

Approved on December 11, 2015, Roche's (RHHBY.OB) Alecensa is indicated for the treatment of people with advanced ALK-positive non-small cell lung cancer whose disease has worsened after, or who could not tolerate treatment with, another therapy called Xalkori.

Non-small cell lung cancer, or NSCLC, is the most common type of lung cancer, accounting for approximately 85-90% of all lung cancers. ALK-positive disease occurs in around 4-5% of non-small cell lung cancers and is more common in males than in females. ALK-positive NSCLC is often found in younger people who have a light or non-smoking history.

Xalkori, marketed by Pfizer Inc. (PFE) is currently the standard-of-care for advanced, treatment-naive ALK-positive NSCLC, and the median progression-free survival for patients on Xalkori is under 12 months.

In one study of patients with metastatic ALK-positive NSCLC whose disease was no longer controlled with Xalkori, treatment with Alecensa twice daily resulted in 38 percent of participants experiencing a partial shrinkage of their NSCLC tumors, an effect that lasted for an average of 7.5 months. In the second study, 44 percent of participants experienced a partial shrinkage of their NSCLC tumors, lasting for an average of 11.2 months.

Since Alecensa has been approved under the accelerated approval regulatory pathway, a confirmatory study is required to verify and describe the clinical benefit of Alecensa.

Alecensa has been available in Japan since September 2014, and is marketed there by Chugai Pharmaceutical Co., Ltd. Global sales of the drug is projected at $1 billion, according to reports.

Kanuma

Approved on December 8, 2015, Kanuma is the first treatment for patients with a rare disease known as lysosomal acid lipase (LAL) deficiency.

LAL deficiency, also known as Wolman disease and cholesteryl ester storage disease, is a rare inherited disorder that affects 25 individuals per million births.

Kanuma, which has the designation of orphan drug, is developed by Alexion Pharmaceuticals Inc. (ALXN), and analysts expect the drug to achieve peak sales of $1.5 billion.

NOVEMBER

Empliciti

Approved on November 30, 2015, Empliciti is indicated for the treatment of people with multiple myeloma who have received one to three prior medications.

Empliciti, co-developed by Bristol-Myers Squibb (BMY) and AbbVie (ABBV), is to be used in combination with another FDA-approved treatment for multiple myeloma called Revlimid, and dexamethasone, a corticosteroid.

Known chemically as elotuzumab, Empliciti works by activating the body's immune system to fight against the cancerous cells.

Portrazza

Approved on November 24, 2015, Portrazza in combination with two forms of chemotherapy - gemcitabine and cisplatin - is indicated for first-line treatment of patients with metastatic squamous non-small cell lung cancer.

Developed by Eli Lilly (LLY), Portrazza is a monoclonal antibody that blocks the activity of EGFR, a protein commonly found on squamous non-small cell lung cancer tumors.

Portrazza, known chemically as necitumumab, is the first biologic to be approved for the first-line treatment of people with metastatic squamous non-small cell lung cancer, and according to reports, it costs about $11,430 a month in the U.S.

The drug sports a boxed warning about potential risks of cardiac arrest and sudden death, as well as hypomagnesemia.

Ninlaro

Approved on November 20, 2015, Takeda Pharmaceutical Co. Ltd.'s Ninlaro is approved to treat people with multiple myeloma who have received at least one prior therapy.

Known chemically as ixazomib, Ninlaro is to be used in combination with another FDA-approved treatment for multiple myeloma called Revlimid and dexamethasone, a type of corticosteroid.

Ninlaro, which has the designation of orphan drug, is a proteasome inhibitor and it works by blocking enzymes from multiple myeloma cells, hindering their ability to grow and survive.

A 28-day cycle of treatment with Ninlaro is list priced at $8,670, according to reports.

Darzalex

On November 16, 2015, Johnson & Johnson (JNJ)/ Genmab's Darzalex was granted accelerated approval to treat patients with multiple myeloma who have received at least three prior treatments.

Known chemically as daratumumab, Darzalex, given as an infusion, is a monoclonal antibody that works by helping certain cells in the immune system attack cancer cells.

With the first full year, requiring 23 infusions, the average monthly *wholesale acquisition cost of Darzalex is said to be $11,212 (Data sourced from FormularyWatch) (*A manufacturer's list price for a drug to wholesalers or direct purchasers, excluding discounts or rebates).

Darzalex carries a breakthrough designation and Orphan drug designation.

Tagrisso

Tagrisso was granted accelerated approval on November 13, 2015 to treat people with a type of advanced non-small cell lung cancer- i.e. for lung cancers with a specific epidermal growth factor receptor (EGFR) mutation called T790M that have gotten worse after treatment with other EGFR-blocking therapy.

Marketed by AstraZeneca Pharmaceuticals (AZN), Tagrisso has a Breakthrough therapy designation and Orphan drug designation.

Tagrisso is the only approved medicine indicated for patients with metastatic EGFR T790M mutation-positive non-small cell lung cancer. A month's supply of Tagrisso is said to cost $12,750 for a patient, according to reports.

The peak annual sales projections of Tagrisso reportedly ranges from $1 billion to $3 billion.

Cotellic

Approved on November 10, 2015, Cotellic is indicated for the treatment of advanced melanoma that has spread to other parts of the body or can't be removed by surgery, and that has a certain type of abnormal gene - say BRAF V600E or V600K mutation.

Cotellic is to be used in combination with Zelboraf, an already approved drug for advanced stages of melanoma, positive for the BRAF V600E mutation.

Known chemically as cobimetinib, Cotellic, designated as an orphan drug, works by preventing or slowing cancer cell growth by blocking the activity of an enzyme known as MEK.

Cotellic and Zelboraf are both marketed by Genentech, a subsidiary of Roche.

The Cotellic/Zelboraf combination treatment reportedly costs $17,600 a month.

Genvoya

Genvoya was approved as a complete regimen for the treatment of HIV-1 infection in adults and pediatric patients 12 years of age and older on November 5, 2015.

The once-daily combination pill Genvoya contains 150 mg of elvitegravir, 150 mg of cobicistat, 200 mg of emtricitabine and 10 mg of tenofovir alafenamide, or TAF. This is the first medication containing TAF to get the U.S. regulatory nod.

Genvoya contains the same ingredients like Stribild, another approved HIV drug except for 1 ingredient. In clinical trials, the safety profile of Genvoya has been better than Stribild.

Marketed by Gilead Sciences Inc. (GILD), Genvoya carries a boxed warning about the risks of lactic acidosis/severe hepatomegaly with steatosis, and post treatment acute exacerbation of hepatitis B.

Stribild, which is also from Gilead's stable, contains 150 mg of elvitegravir, 150 mg of cobicistat, 200 mg of emtricitabine, and 300 mg of tenofovir disoproxil fumarate or TDF. Stribild logged in sales of $1.31 billion in the 9 months of 2015.

Nucala

GlaxoSmithKline plc's (GSK) Nucala was approved on November 4, 2015 for use with other asthma medicines for the maintenance treatment of asthma in patients age 12 years and older.

Known chemically as mepolizumab, Nucala is for patients who have a history of severe asthma attacks despite receiving their current asthma medicines.

Nucala is the first and only approved biologic therapy that targets interleukin-5 (IL-5), which plays an important role in regulating the function of eosinophils, an inflammatory cell known to be important in asthma.

The current list price of Nucala is $32,500 a year, according to reports.

ICER, a non-profit organization that performs analyses on effectiveness and costs, in a recent report has pointed out that Nucala is over-priced and it has to be in the range of $7,787 to $12,116 per year.

OCTOBER

Strensiq

Approved on October 23, 2015, Alexion Pharmaceuticals Inc.'s (ALXN) Strensiq is indicated for the treatment of perinatal, infantile and juvenile-onset hypophosphatasia, fatal metabolic bone disease.

Hypophosphatasia, or HPP, is a genetic, chronic, and progressive ultra-rare metabolic disease in which patients experience devastating effects on multiple systems of the body, leading to debilitating or life-threatening complications.

Strensiq, which carries a Breakthrough therapy designation and Orphan drug designation is priced at $285,000 for a year's treatment in the U.S.

Analysts project peak sales of Strensiq to reach $1 billion.

Yondelis

Approved on October 23, 2015, Johnson & Johnson's (JNJ) Yondelis is indicated for the treatment of specific soft tissue sarcomas namely, liposarcoma and leiomyosarcoma that cannot be removed by surgery or is advanced.

Liposarcoma is a cancer that starts in fat cells, while leiomyosarcoma starts in smooth muscle cells.

Known chemically as trabectedin, Yondelis was rejected by the FDA in 2009 as a treatment for relapsed ovarian cancer, in combination with the company's already approved ovarian cancer drug Doxil.

Yondelis carries a boxed warning about the risk of severe and fatal blood infections, muscle tissue breakdown, liver damage, leakage of the drug around the vein or catheter, tissue breakdown, and heart failure.

A vial of Yondelis is priced at about $2,700 in the United State and an average patient requires 3 vials per infusion, according to Thomson Reuters.

Veltassa

Approved on October 21, 2015, Relypsa Inc.'s (RLYP) Veltassa is indicated for treatment of hyperkalemia, a serious condition in which the amount of potassium in the blood is too high. It is the first new medicine for the treatment of hyperkalemia in more than 50 years.

Known chemically as patiromer, Veltassa, a powdered medication that patients mix with water and take by mouth, works by binding potassium in the gastrointestinal tract, decreasing its absorption.

Veltassa carries a black box warning - alerting patients that it binds many other orally administered drugs, which could decrease their absorption and reduce their effects.

The wholesale acquisition cost for a 30-day pack of Veltassa is $595, according to reports.

Praxbind

On October 16, 2015, Praxbind was granted accelerated approval to reverse the anticoagulant effects of Pradaxa during emergency situations.

The FDA approved Pradaxa in 2010 to prevent stroke and systemic blood clots in patients with atrial fibrillation, as well as for the treatment and prevention of deep venous thrombosis and pulmonary embolism.

Known chemically as idarucizumab, Praxbind works by binding to Pradaxa to neutralize its effect.

Praxbind and Pradaxa are both marketed by Boehringer Ingelheim.

The wholesale acquisition cost for a single administration of Praxbind is about $3,500 in the U.S.

Aristada

Approved on October 6, 2015, Alkermes Inc.'s (ALKS) Aristada is indicated for the treatment of schizophrenia in adults.

Known chemically as aripiprazole lauroxil, Aristada is administered as an injection every four to six weeks.

Aristada, which costs about $1,500 a month, sports a black box warning about an increased risk of death in elderly patients with dementia-related psychosis.

SEPTEMBER

Tresiba

On September 25, 2015, Novo Nordisk's (NVO) diabetes drug Tresiba finally got the much awaited FDA approval.

Tresiba marks the first new basal insulin molecule to be approved by the FDA in 10 years. Tresiba, known chemically as insulin degludec, is a once-daily new-generation basal insulin analogue with a half-life of 25 hours and a duration of action of at least 42 hours.

Lonsurf

Approved on September 22, 2015, Lonsurf is used for treating patients with an advanced form of colorectal cancer who are no longer responding to other therapies.

Manufactured by Taiho Oncology Inc., Lonsurf is a combination of two drugs, trifluridine and tipiracil.

Lonsurf was approved in Japan in March 2014.

Vraylar

Approved on September 17, 2015, Vraylar is for treating schizophrenia and bipolar disorder in adults.

Known chemically as cariprazine, Vraylar was turned down by the FDA in November 2013. Analysts expect Allergan's Vraylar to achieve annual peak sales of about $500 million.

Like all other schizophrenia and bipolar disorder drugs, Vraylar sports a black box warning about an increased risk of death in elderly patients with dementia-related psychosis.

Xuriden

Approved on September 4, 2015, Xuriden is indicated for the treatment of patients with hereditary orotic aciduria, a rare metabolic disorder, which has been reported in approximately 20 patients worldwide.

Hereditary orotic aciduria, caused by a defective or deficient enzyme uridine-5'-monophosphate (UMP) synthase, is characterized by retarded growth, anemia, excessive urinary excretion of orotic acid, failure to thrive and developmental delays.

Developed by privately-held Wellstat Therapeutics Corp., Xuriden, known chemically as uridine triacetate, is formulated as oral granules, which can be mixed with food or in milk or infant formula and administered once daily.

Xuriden, which has the orphan drug designation, is expected to be commercially available in early 2016.

Varubi

Approved on September 2, 2015, Tesaro Inc.'s (TSRO) Varubi is indicated to prevent delayed nausea and vomiting in adults associated with cancer chemotherapy.

Known chemically as rolapitant, Varubi is to be used in combination with a 5-HT3 receptor antagonist and dexamethasone.

AUGUST

Repatha

Approved on August 27, 2015, Amgen's (AMGN) Repatha is for the treatment of certain patients with high cholesterol.

Known chemically as evolocumab, Repatha is indicated as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia (HeFH) or clinical atherosclerotic cardiovascular disease (ASCVD), who require additional lowering of LDL-C; and as an adjunct to diet and other LDL-lowering therapies for the treatment of patients with homozygous familial hypercholesterolemia (HoFH), who require additional lowering of LDL-C.

The U.S. Wholesale Acquisition Cost price of Repatha is $542.31 for one 140 mg single-use prefilled SureClick autoinjector or prefilled syringe, or $14,100 annually. Repatha is administered once every two weeks.

Addyi

Approved on August 18, 2015, Addyi (pronounced add-ee) is for the treatment of acquired, generalized hypoactive sexual desire disorder in premenopausal women, which is the most common form of female sexual dysfunction.

Addyi can cause severely low blood pressure (hypotension) and loss of consciousness (syncope). These risks are increased and more severe when patients drink alcohol or take Addyi with certain medicines (known as moderate or strong CYP3A4 inhibitors) that interfere with the breakdown of Addyi in the body, the FDA has warned.

Known chemically as flibanserin, Addyi sports a boxed warning about the potential for increased hypotension or syncope with alcohol.

Addyi is the first and only FDA-approved treatment for hypoactive sexual desire disorder.

Developed by Boehringer Ingelheim and then sold to Sprout Pharmaceuticals, Addyi is now under the aegis of Valeant Pharmaceuticals International, Inc., following the acquisition of Sprout soon after the drug's approval.

JULY

Daklinza

Approved on July 24, 2015, Bristol-Myers Squibb's (BMY) Daklinza is indicated for use with Gilead's Sovaldi to treat hepatitis C virus genotype 3 infections.
Genotype 3 is a hard to treat and aggressive form of hepatitis C.

Sovaldi as a component of a combination antiviral treatment regimen for use in genotypes 1,2,3 and 4 was approved in December 2013.

Daklinza plus Sovaldi is a new treatment option for patients with genotype 3 HCV, including those who cannot tolerate ribavirin.

Daklinza's list price in the U.S. is $63,000 and that of Sovaldi is $84,000 for a 12-week treatment, according to reports.

Odomzo

Novartis' (NVS) Odomzo was approved on July 24, 2015, for locally advanced basal cell carcinoma, a form of skin cancer.

Known chemically as sonidegib, Odomzo works by inhibiting a molecular pathway, called the Hedgehog pathway, which is active in basal cell cancers.
Odomzo is the second drug to be approved for locally advanced and metastatic basal cell carcinoma. The first drug to pass FDA muster for this disease was Erivedge and in the year 2012.

Odomzo carries a Boxed Warning alerting that it may cause death or severe birth defects in a developing foetus when administered to a pregnant woman.

Praluent

Approved on July 24, 2015, Praluent is indicated for treating certain patients with high cholesterol.

Known chemically as alirocumab, Praluent is for use as an adjunct to diet and maximally tolerated statin therapy in adult patients with heterozygous familial hypercholesterolemia (HeFH) or patients with clinical atherosclerotic cardiovascular disease such as heart attacks or strokes, who require additional lowering of LDL cholesterol.

Praluent, developed by Sanofi (SNY) and Regeneron Pharmaceuticals (REGN), carries a price tag of $14,600 per patient per year, according to reports.

Rexulti

Approved on July 10, 2015, Rexulti is indicated for the treatment of adults with schizophrenia and as an add-on treatment to an antidepressant medication to treat adults with major depressive disorder.

Known chemically as brexpiprazole, Rexulti is manufactured by Tokyo-based Otsuka Pharmaceutical Co. Ltd.

Like all other schizophrenia and bipolar disorder drugs, Rexulti sports a black box warning about an increased risk of death in elderly patients with dementia-related psychosis.

Entresto

Approved on July 7, 2015, Entresto is indicated for the treatment of heart failure.

Known chemically as sacubitril/valsartan, Entresto, developed by Novartis has been shown to reduce the rate of cardiovascular death and hospitalization related to heart failure.

The list price of Entresto is $4,560 per year, and analysts expect the drug to achieve peak sales of over $5 billion.

Orkambi

Approved on July 2, 2015, Orkambi is for use in people with cystic fibrosis ages 12 and older who have two copies of F508del mutation in the CFTR gene.

Developed by Vertex Pharmaceuticals Inc. (VRTX), Orkambi is a combination of an approved drug Kalydeco and Lumacaftor. Kalydeco is also from the stable of Vertex Pharma.

Orkambi, which is designated an orphan drug, has a list price of $259,000 a year, according to reports.

JUNE

Kengreal

The Medicines Co.'s (MDCO) Kengreal was approved on June 22, 2015 to prevent formation of harmful blood clots in the coronary arteries for adult patients undergoing percutaneous coronary intervention.

Known chemically as cangrelor, Kengreal is an intravenous antiplatelet drug, and as with other anti-platelet drugs, bleeding is the most serious risk.

Kengreal, which is the first and only intravenous P2Y12 platelet inhibitor that blocks platelet activation and aggregation, has a wholesale acquisition cost of $749, according to reports.

MAY

Viberzi

On May 27, 2015, Viberzi was approved for the treatment of irritable bowel syndrome with diarrhea (IBS-D) in adult men and women.

Known chemically as eluxadoline, Viberzi is manufactured by Patheon Pharmaceuticals Inc., and is taken orally twice daily with food.

Viberzi, which has a mixed opioid receptor activity, is awaiting final scheduling designation as a controlled substance. The product is expected to be launched in Q1, 2016.

APRIL

Kybella

Approved on April 29, 2015, Kythera Biopharmaceuticals Inc.'s (KYTH) Kybella is for use in adults with moderate-to-severe fat below the chin, known as submental fat.

Known chemically as deoxycholic acid, Kybella is administered as an injection into the fat tissue in the submental area to destroy the fat cells.

Patients may receive up to 50 injections in a single treatment, with up to six single treatments administered no less than one month apart.

Using Kybella for the treatment of fat outside of the submental area is not approved and is not recommended.

Kybella, which is the first and only approved non-surgical treatment for reduction of submental fullness, is expected to generate over $500 million in annual sales.

Corlanor

Approved on April 15, 2015, Corlanor is for use in reducing the risk of hospitalization for worsening heart failure in patients with chronic heart failure.

The drug is indicated for patients who have symptoms of heart failure that are stable, a normal heartbeat with a resting heart rate of at least 70 beats per minute and are also taking beta blockers at the highest dose they can tolerate.

Known chemically as ivabradine, Corlanor works to slow the heart rate by inhibiting the If current ("funny" current) in the sinoatrial node, the natural pacemaker of the heart. This is the first new chronic heart failure medicine approved in the U.S. in nearly a decade.

Amgen Inc. (AMGN) gained U.S. rights to Corlanor from Les Laboratoires Servier through a product collaboration that was signed between the two companies in 2013.

Sold under the brand name Procoralan by Servier, the drug was approved by the European Medicines Agency in 2005 for the symptomatic treatment of stable angina and in 2012 for chronic heart failure in patients with elevated heart rates.

MARCH

Unituxin

On March 10, 2015, United Therapeutics Corp.'s (UTHR) Unituxin was approved as part of first-line therapy for pediatric patients with high-risk neuroblastoma, a cancer which affects the peripheral nervous system.

Known chemically as dinutuximab, Unituxin is the first immunotherapy drug for children with cancer, and is only the third drug that has received initial FDA approval for a pediatric cancer in over 20 years. Clolar for the treatment of children with refractory or relapsed acute lymphoblastic leukemia (ALL) was approved in 2004 and Erwinaze for the treatment of pediatric acute lymphoblastic leukemia (ALL) was approved in November 2011.

Unituxin irritates nerve cells, causing severe pain that requires treatment with intravenous narcotics and can also cause nerve damage and life-threatening infusion reactions, including upper airway swelling, difficulty breathing, and low blood pressure, during or shortly following completion of the infusion.

The drug sports a Boxed Warning about the serious side effects associated with its use.

Cholbam

Approved on March 17, 2015, Cholbam is a once-daily treatment for cholic acid deficiency in bile acid synthesis disorders due to single enzyme defects.

Developed by Asklepion Pharmaceuticals LLC, Cholbam is the first FDA approved treatment for pediatric and adult patients with bile acid synthesis disorders due to single enzyme defects, and for patients with peroxisomal disorders (including Zellweger spectrum disorders).

Retrophin (RTRX) acquired all worldwide rights to Cholbam under an agreement that was signed with Asklepion.

Known chemically as cholic acid, Cholbam is designated an orphan drug, entitling it for seven years' market exclusivity in the United States.

With the wholesale acquisition cost of $830 per capsule, a year's treatment with Cholbam will be more than $13,284, according to Priority Health.

Cresemba

Approved on March 6, 2015, Cresemba is an antifungal drug to treat adults with invasive aspergillosis and invasive mucormycosis.

Developed by Astellas in partnership with Basilea Pharmaceutica International Ltd., Cresemba belongs to a class of drugs called azole antifungal agents, which target the cell membrane of a fungus.

Known chemically as isavuconazonium sulfate, Cresemba is available in oral and intravenous formulations.

FEBRUARY

Avycaz

Approved on February 25, 2015, Avycaz is for the treatment of adults with complicated intra-abdominal infections (cIAI), in combination with metronidazole, and complicated urinary tract infections (cUTI), including kidney infections (pyelonephritis).

Owned by Actavis plc (ACT), Avycaz is a fixed-combination drug containing Ceftazidime, an approved antibiotic, and Avibactam, a new beta-lactamase inhibitor.

Avycaz works by inhibiting a broad range of ß- lactamases, including Class A (Extended-Spectrum ß-Lactamases and Klebsiella pneumoniae carbapenemase), Class C (AmpC) and some class D enzymes produced by Gram-negative pathogens that are encountered in the hospital setting and involved in some of the most serious infections like cIAI and cUTI.

Avycaz is approved as a Qualified Infectious Disease Product, making it eligible for a five-year regulatory extension of exclusivity under the Hatch-Waxman Act.

Farydak

On February 23, 2015, Farydak was granted accelerated approval for the treatment of multiple myeloma.

The drug is to be used in combination with Velcade and dexamethasone for the treatment of patients with multiple myeloma who have received at least two prior treatment regimens.

Developed by Novartis (NVS), Farydak works by inhibiting histone deacetylase enzymes that play a role in the development and progression of cancer.

Since Farydak is approved under accelerated approval based on progression-free survival, continued approval may be contingent upon verification and description of clinical benefit in confirmatory trials.

The drug carries a boxed warning about fatal and serious toxicities, including severe diarrhea and cardiac toxicities.

Lenvima

Approved on February 13, 2015, Lenvima is for treating patients with a type of thyroid cancer known as differentiated thyroid cancer (DTC) whose disease progressed despite receiving radioactive iodine therapy.

Differentiated thyroid cancer is the most common form of thyroid cancer and is said to account for approximately 95% of all thyroid cancers.

Known chemically as lenvatinib, Lenvima is designated an orphan drug. It is developed by Eisai Co., Ltd., and works by blocking certain proteins like VEGFR, FGFR and also RET from helping cancer cells grow and divide.

Ibrance

On February 3, 2015, Ibrance was granted accelerated approval for the treatment of postmenopausal women with advanced (metastatic) breast cancer. The drug is to be used in combination with letrozole, another FDA-approved product used to treat certain kinds of breast cancer in postmenopausal women.

Developed by Pfizer Inc. (PFE), Ibrance works by inhibiting molecules, known as cyclin-dependent kinases (CDKs) 4 and 6, involved in promoting the growth of cancer cells. This drug is the first CDK 4/6 inhibitor to be approved by the FDA.

Given the fact that Ibrance has been approved under accelerated approval based on progression-free survival, continued approval may be contingent upon verification and description of clinical benefit in a phase III confirmatory trial.

Known chemically as palbociclib, Ibrance has a wholesale acquisition price of $128,037 per year (Data sourced from pharmacy benefit manager Prime Therapeutics).

JANUARY

Natpara

Approved on January 23, 2015, Natpara is to control hypocalcemia (low blood calcium levels) in patients with hypoparathyroidism.

Developed by NPS Pharmaceuticals, which was acquired by Shire earlier this year, Natpara is a bioengineered replica of human parathyroid hormone. It is administered by injection once daily, and offers an alternative to patients whose calcium levels cannot be controlled on calcium supplementation and active forms of vitamin D.

Natpara, which is designated an orphan drug, carries a boxed warning on the potential risk of bone cancer (osteosarcoma).

The drug is expected to garner peak sales of about $760 million in 2024, according to GlobalData.

Cosentyx

Approved on January 21, 2015, Novartis' (NVS) Cosentyx is for the treatment of adults with moderate-to-severe plaque psoriasis.

Cosentyx, administered as an injection under the skin, works by inhibiting the action of IL-17A, a protein that is found in high concentrations in skin affected by psoriasis. Known chemically as secukinumab, Cosentyx is the first and only approved treatment targeting the IL-17 pathway.

Cosentyx is approved with a Medication Guide, warning patients that the drug may increase the risk of getting an infection.

The drug has the potential to become a blockbuster, according to analysts.

Savaysa

Approved on January 8, 2015, Savaysa is for use in reducing the risk of stroke and dangerous blood clots (systemic embolism) in patients with atrial fibrillation that is not caused by a heart valve problem, and for the treatment of deep vein thrombosis, and pulmonary embolism.

Known chemically as edoxaban, Savaysa is an oral, once-daily drug that works by inhibiting factor Xa, which is important in the clotting of blood.

Developed by Tokyo-based Daiichi Sankyo Co. Ltd., Savaysa is the fourth new oral anticoagulant (NOAC) to be approved by the FDA . The other three being - Boehringer Ingelheim's Pradaxa (approved on October 19th, 2010), Janssen's Xarelto (July 1st, 2011) and Bristol-Myers Squibb/Pfizer's Eliquis (December 28th, 2012).

Like the other FDA-approved NOAC medications, Savaysa also sports a black-box warning that it is less effective in atrial fibrillation patients with a creatinine clearance greater than 95 milliliters per minute.

Source : FDA's New Molecular Entity and New Therapeutic Biological Product Approvals for 2015.

Will the number of novel new drug approvals increase, sink or remain flat in 2016?

Watch this space!

For comments and feedback contact: editorial@rttnews.com

Business News