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New Drugs Approved In January

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The Food and Drug Administration approved four new drugs last month. In the year 2020, 104 new drugs were approved by the FDA. Now, let us take a look at the new drugs approved by the regulator in January 2021.

Verquvo

The FDA approved Verquvo (vericiguat), developed by Merck & Co., Inc. (MRK) and Bayer AG. on January 19, 2021 for the treatment of heart failure with ejection fraction (HFrEF) less than 45%.

Verquvo (vericiguat), a soluble guanylate cyclase (sGC) stimulator is the first treatment for chronic heart failure approved specifically for patients following a hospitalization for heart failure or need for outpatient IV diuretics.

Verquvo is entering the already congested market with competitors including Novartis' Entresto and AstraZeneca's Farxiga, among others.

Bayer expects the drug to bring in sales of $570 million at its peak.

Verquvo comes with a boxed warning indicating that it should not be administered to pregnant women as it may cause fetal harm.

As per the deal signed in 2014, Merck has the commercial rights to Verquvo in the U.S. and Bayer has the exclusive commercial rights in the rest of world. The drug is under review in European Union, Japan and China along with other countries.

Cabenuva

Cabenuva (cabotegravir, rilpivirine), developed by privately-held ViiV Healthcare, was approved by the FDA on January 21, 2021, for the treatment of HIV-1 infection in adults.

The drug comes as a co-pack with two injectable medicines — ViiV Healthcare's cabotegravir and Janssen's rilpivirine.

Cabenuva is indicated as a complete regimen for the treatment of HIV-1 infection in adults to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine.

Cabotegravir, which was also approved on January 21, 2021, is indicated, in combination with rilpivirine, as a complete regimen for short-term treatment of HIV-1 infection in adults who are virologically stable and suppressed (HIV-1 RNA less than 50 copies/mL) on a stable ARV regimen with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine.

Rilpivirine is approved for the treatment of HIV-1 in combination with other antiretroviral agents in antiretroviral treatment-naïve patients 12 years of age and older and weighing at least 35-kg with a viral load = 100,000 HIV RNA copies/mL.

Prior to initiating treatment of Cabenuva, oral dosing of cabotegravir and rilpivirine should be administered for about one month to assess the tolerability of each therapy.

During clinical trials with Cabenuva, adverse reactions including Hypersensitivity reactions, Serious post-injection reactions, Hepatotoxicity, and depressive disorders have been reported.

The wholesale acquisition cost for the drug is $3,960 for one month.

Lupkynis

The FDA green lighted Lupkynis, developed by Aurinia Pharmaceuticals Inc. (AUPH) on January 22, 2021.

Lupkynis (voclosporin) is approved in combination with a background immunosuppressive therapy regimen to treat adult patients with active lupus nephritis (LN).

Lupus nephritis (LN) is a serious progression of systemic lupus erythematosus (SLE), a chronic, complex, autoimmune disease, that causes irreversible kidney damage.

Lupkynis is the first FDA-approved oral therapy for LN.

The drug comes with boxed warning about increased risk for developing malignancies and serious infections that may lead to hospitalization or death.

GlaxoSmithKline's Benlysta, which is to be administered intravenously,is the only other approved therapy for LN.

Aurinia Pharmaceuticals has set the list price of Lupkynis at $3,950 for 60 capsules.

According to the company, the global peak sales of Lupkynis are estimated to be more than $1 billion.

The most common adverse events associated with Lupkynis included decreased glomerular filtration rate, hypertension, diarrhea, headache, anemia, urinary tract infection, abdominal pain upper, dyspepsia, alopecia, renal impairment, abdominal pain, mouth ulceration, fatigue, tremor, acute kidney injury and decreased appetite.

Lupkynis is now available in the U.S.

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