Gilead (GILD) Truvada Gets EU Approval For Label Expansion

Gilead Sciences Inc. (NASDAQ:GILD) received encouraging news when the European Commission approved its marketing authorization for once-daily Truvada (Emtriva 200 mg/tenofovir disoproxil 245 mg), making it the first antiretroviral treatment to be approved in Europe for pre-exposure prophylaxis (PrEP), in combination with safer sex practices, to reduce the risk of sexually acquired HIV-1 infection among uninfected adults at high risk.

EU approval was largely expected as the Committee for Medicinal Products for Human Use had issued a favorable opinion this July.

We remind investors that Truvada is already approved in Europe in combination with other antiretroviral agents for the treatment of adults with HIV-1 infection. Currently, it is the most prescribed antiretroviral drug in Europe as part of combination therapy.

We are encouraged by the recent label expansion of Truvada. Truvada for PrEP is expected to provide an additional prevention option for uninfected adults at high risk of HIV, which will lead to a significant reduction in HIV transmission rates across Europe, when used in combination with safer sex practices.

We note that Truvada for PrEP is already approved in the U.S. and several other countries. In the first half of 2016, Truvada recorded sales of $1.8 billion, up 13.6% year over year. The growth was mainly due to higher sales volume, reflecting increased usage of Truvada for PrEP. On its second-quarter 2016 call, Gilead drew attention to the growing use of Truvada for PrEP in the U.S.

HIV is one of the primary areas of focus for Gilead and the company is striving to bring new treatments to market to drive sales of the franchise. In particular, recent launched tenofovir alafenamide-based regimens, including Genvoya, Odefsey and Descovy.

Gilead is a Zacks Rank #3 (Hold) stock. Some better-ranked stocks in the health care sector include Anika Therapeutics Inc. (NASDAQ:ANIK) , Geron Corporation (NASDAQ:GERN) and Corcept Therapeutics Incorporated (NASDAQ:CORT) . All the three stocks sport a Zacks Rank #1 (Strong Buy).