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Gilead's (GILD) Cocktail HIV Drug Genvoya Gets FDA Nod

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Gilead Sciences, Inc. 's GILD announced that the first tenofoviralafenamide (TAF)-based HIV drug, Genvoya, has been approved by the FDA. Genvoya, the TAF-based single-tablet regimen comprises TAF, Vitekta (elvitegravir), Tybost (cobicistat) and Emtriva.

The FDA cleared Genvoya for the treatment of HIV-1 infection in adults and pediatric patients above 12 years who have no antiretroviral treatment history, or the replacement of the current antiretroviral regimen in those who are virologically suppressed on a stable antiretroviral regimen for at least six months with no history of treatment failure and no known substitutions associated with resistance to the individual components of Genvoya.

However, we note that Genvoya carries a boxed warning regarding the risks of lactic acidosis/severe hepatomegaly with steatosis, and post-treatment acute exacerbation of hepatitis B.

Other TAF-based Regimens at Gilead

HIV is one of the primary areas of focus for the company. Currently, Gilead has two other TAF-based regimens under regulatory review in the U.S. In Apr 2015, Gilead filed a regulatory application for two doses of a fixed-dose combination of Emtriva and TAF for HIV-1 infection. A final decision from the FDA is expected by Apr 7, 2016.

The company has also submitted a new drug application (NDA) to the FDA for a once-daily single-tablet regimen comprising its Emtriva and TAF, along with Johnson & Johnson's JNJ Edurant (rilpivirine) for the treatment of HIV-1 infection in adults and pediatric patients above 12 years. We note that Gilead has submitted a priority review voucher along with the NDA to the FDA. A priority review would shorten the review period of the candidate to six months. A final decision is expected by Mar 1, 2016.

Gilead's pipeline includes a fourth TAF-based regimen comprising TAF, Emtriva, Tybost and Johnson & Johnson's Prezista (darunavir).

Our Take

We are pleased with the approval of the first TAF-based HIV drug at Gilead. We believe that TAF-based regimens would complement the company's current portfolio. Gilead's portfolio includes several drugs targeting HIV, of which Tybost and Vitekta were approved last year.

Meanwhile, Gilead's HCV drugs have been witnessing a slowdown in sales. In the third quarter of 2015, Sovaldi sales plunged 47.6% from a year ago owing to the availability of newer HCV therapies. Another new HCV drug, Harvoni, witnessed a sequential fall in revenues due to a gradual decrease in demand from the retail market during the quarter. In this scenario, the approval of Genvoya is a major win for the company.

Gilead currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include Anika Therapeutics Inc. ANIK and Baxalta Inc. BXLT . Both Anika and Baxalta carry a Zacks Rank #1 (Strong Buy).

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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.


The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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