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New Drugs Approved In July

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In the month of July, 9 drugs were approved by the FDA, including novel drugs and biosimilars.


The FDA approved SIGA Technologies Inc.'s (SIGA) oral TPOXX, also known as Tecovirimat and ST-246, for the treatment of smallpox on July 13.

Smallpox, one of the most deadly diseases known to humanity, is caused by Variola virus, a member of the genus Orthopoxvirus. The last known natural case of smallpox was reported in Somalia in 1977, and it was declared eradicated in 1980.

Only two labs in the world have been permitted to store the smallpox virus for research - the Centers for Disease Control and Prevention (CDC) in the United States, and the Russian State Centre for Research on Virology and Biotechnology in the Russian Federation. There have been concerns that some countries could employ smallpox in a bioterrorism attack.


The FDA approved Symtuza by Janssen Pharmaceuticals on July 17, for the treatment of HIV Infection. It is the first and only complete, darunavir-based single-tablet regimen (STR) for the treatment of human immunodeficiency virus type 1 (HIV-1) in treatment-naïve and certain virologically suppressed adults.

The wholesale acquisition cost of Symtuza is $41,784 a year, which is $4,700 to $6,400 more than other single-tablet antiretroviral regimens like Stribild, Genvoya, and Biktarvy, according to Fair Pricing Coalition.

Symtuza was approved in the European Union in September, 2017, and in Canada in March 2018.

According to Global Data, Symtuza is expected to reach peak global sales of $860 million in 2024.


The FDA approved Pfizer Inc.'s (PFE) Nivestym, a biosimilar to Amgen's Neupogen on July 20.

This is the second Neupogen biosimilar in the U.S. The first biosimilar to Amgen's Neupogen that won FDA approval is Sandoz Inc.'s Zarxio. It was greenlighted in the U.S. in March 2015.

Nivestym is indicated for all eligible indications as that of Neupogen namely,

For patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a significant incidence of severe neutropenia with fever.

For patients with acute myeloid leukemia receiving induction or consolidation chemotherapy.

For patients with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by bone marrow transplantation

For patients undergoing autologous peripheral blood progenitor cell collection and therapy.

For patients with congenital neutropenia, cyclic neutropenia, or idiopathic neutropenia.

Amgen's Neupogen generated $549 million in sales last year.


Tibsovo (ivosidenib), developed by Agios Pharmaceuticals Inc. (AGIO), was approved by FDA on July 20, for relapsed or refractory acute myeloid leukemia patients with an IDH1 mutation.

Isocitrate dehydrogenase (IDH) 1 and 2 are metabolic enzymes that are mutated in a wide range of blood and solid tumor cancers.

Acute myelogenous leukemia (AML) is a cancer of blood and bone marrow characterized by rapid disease progression. AML Patients with IDH1 and IDH2 mutations represent about 20% of all patients with AML.

The drug has been launched, and according to reports, the wholesale price for a 30-day supply of Tibsovo is $26,115.


Krintafel (Tafenoquine) was granted FDA approval on July 20, for the radical cure (prevention of relapse) of Plasmodium vivax (P. vivax) malaria in patients 16 years of age and older.

Developed in collaboration by GlaxoSmithKline and the not-for-profit Medicines for Malaria Venture, Krintafel is the first new medicine for the prevention of relapse of P vivax malaria in more than 60 years.


Orilissa (elagolix) won FDA approval on July 23, for the treatment of endometriosis-associated pain.

Developed by AbbVie (ABBV) and Neurocrine Biosciences Inc. (NBIX), Orilissa is a novel, orally administered gonadotropin-releasing hormone (GnRH) antagonist, and is the first new oral medical management treatment option for endometriosis-associated pain in more than a decade.

Abbvie plans to launch the drug by early August at a wholesale acquisition cost of $844.87 per month.

Analysts at Evaluate Pharma expect the drug to reach $1.21 billion in sales in 2022.


The FDA approved Perseris (risperidone) on July 27, for the treatment of schizophrenia.

The drug, developed by Indivior Inc., is a novel extended-release product that uses the ATRIGEL delivery system for the subcutaneous administration of Risperidone once every month.

Perseris is yet to be launched, and Indivior expects peak sales of $200 million to $300 million for the drug.

Perseris may face completion from other once-monthly injectable medications like Lundbeck/Otsuka's Abilify Maintena (aripiprazole) and Johnson & Johnson's Invega Sustenna (paliperidone).

Last year, the sales of Abilify Maintena increased 24.2% to $709 million and that of Invega Sustenna were up 16% to $1.569 billion.


Azedra, a radioactive therapeutic, developed by Progenics Pharmaceuticals Inc. (PGNX), won FDA approval for the treatment of locally advanced or metastatic pheochromocytoma and paraganglioma on July 30.

Pheochromocytoma and Paraganglioma are rare and life-threatening neuroendocrine cancers, and Azedra is the first and only approved therapy for these indications.

Analysts expect Azedra to rake in peak sales of between $200 million and $300 million.


Mulpleta (lusutrombopag), developed by Shionogi Inc., was approved by the FDA on July 31, for treating thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo a procedure.

Thrombocytopenia is a common complication of chronic liver disease, or CLD, and is characterized by low platelet count in the blood. Patients with CLD and thrombocytopenia are at increased risk for bleeding, requiring recurrent platelet transfusions, increased ambulatory visits and inpatient hospital stays compared with patients with CLD without thrombocytopenia.

Mulpleta, a thrombopoietin (TPO) receptor agonist, is the second drug to be greenlighted by the FDA for this indication.

In May of this year, Dova Pharmaceuticals Inc.'s (DOVA) Doptelet, which is also a thrombopoietin receptor agonist, secured FDA approval for the treatment of thrombocytopenia in patients with chronic liver disease who are scheduled to undergo a medical procedure.

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