$GILD Submits Regulatory Application for HIV Drug in U.S. – Analyst Blog

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Gilead Submits Regulatory Application for HIV Drug in U.S. – Analyst Blog

Gilead Sciences, Inc. GILD announced that it has submitted a new drug application (NDA) to the FDA for two doses of a fixed-dose combination of Emtriva (emtricitabine) and tenofovir alafenamide (TAF) for the treatment of adults suffering from HIV-1 infection in pediatric patients above 12 years, in combination with other HIV antiretroviral drugs.

Gilead plans to submit a marketing authorization application to the European Commission (EC) for Emtriva (emtricitabine) and tenofovir alafenamide (TAF) in the second quarter of 2015.

We remind investors that this is the second TAF-based regulatory application that the company has submitted to the FDA. Last November, the company had submitted an NDA to the FDA for another TAF-based single tablet regimen (STR) comprising TAF, Vitekta (elvitegravir), Tybost (cobicistat) and Emtriva, for the treatment of adults suffering from HIV-1 infection.

The FDA is expected to render a final decision on the regulatory application for the TAF, Vitekta, Tybost and Emtriva combination STR by Nov 5, 2015. The company is also looking to get the combination approved in the EU. The EC has validated the marketing application on Dec 23, 2014.

Our Take

We are pleased with the pipeline progress at Gilead. If approved, we believe that the TAF-based regimens would complement the company’s current portfolio. Gilead’s portfolio includes several drugs targeting HIV among which Tybost and Vitekta were approved last year.

Johnson & Johnson’s JNJ Edurant is another currently approved HIV drug.

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