The U.S. Food and Drug Administration (FDA) has accepted Gilead Sciences’ application to give priority review of Truvada (emtricitabine and tenofovir) as pre-exposure prophylaxis (PrEP), according to a Gilead statement. This PrEP is when an HIV-negative person takes a daily dose of Truvada as a means to lower the chance of contracting the virus during sex. The FDA grants fast-track appraisal to drug applicants that demonstrate major advances in treatment or provide a treatment where no adequate or current therapy exists. Approval of the supplemental New Drug Application (sNDA) will be discussed at the FDA Antiviral Drugs Advisory Committee in May. The target review date is June 15.
From the Newsfeed: New Three-in-One HIV Med Complera Approved
Complera, a complete single-tablet regimen containing Janssen Therapeutics’ Edurant (rilpivirine) and Gilead Sciences’ Viread (tenofovir) and Emtriva (emtricitabine), was approved August 10 by the U.S. Food and Drug Administration (FDA), according to an announcement by Gilead. Complera, the second all-in-one fixed-dose combination tablet for people living with HIV, is approved for those starting antiretroviral (ARV) therapy for the first time.
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