FDAnews Drug Daily Bulletin
Pharmaceuticals / Submissions and Approvals

Gilead’s HIV Drug Approved in China

Dec. 12, 2018
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The China National Medical Products Administration has approved Gilead’s fixed-dose combination HIV treatment Descovy (emtricitabine and tenofovir alafenamide).

Descovy is indicated in China for treating, in combination with other antiretroviral agents, HIV-1 patients aged 12 and older that weigh at least 77 lbs. Its approval stems from results of two Phase 3 studies that met their primary objectives of non-inferiority compared to a Stribild regimen.

Descovy comes with a boxed warning in the U.S. regarding the risks of post treatment acute exacerbation of hepatitis B. It received FDA and European Commission marketing approval in 2016.

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