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Descovy Approval History

  • FDA approved: Yes (First approved April 4th, 2016)
  • Brand name: Descovy
  • Generic name: emtricitabine and tenofovir alafenamide
  • Dosage form: Tablets
  • Company: Gilead Sciences, Inc.
  • Treatment for: HIV Infection

Descovy (emtricitabine and tenofovir alafenamide) is a nucleoside analog HIV-1 reverse transcriptase inhibitor (NRTI) and nucleotide reverse transcriptase inhibitor (NtRTI) fixed-dose combination for the treatment of HIV-1 infection.

FDA approval of Descovy was supported by data from clinical studies which demonstrated that a tenofovir alafenamide (TAF) based regimen was as effective as a tenofovir disoproxil fumarate (TDF) based regimen in reducing viral loads, but with with less kidney toxicity and bone loss. Descovy is intended to be a safer replacement for Truvada (emtricitabine/tenofovir disoproxil fumarate (TDF), but unlike Truvada, Descovy is not approved for pre-exposure prophylaxis (PrEP).

The recommended dosage for Descovy is one tablet taken once daily with or without food. The most common side effect is nausea.

Development History and FDA Approval Process for Descovy

DateArticle
Apr  4, 2016Approval FDA Approves Descovy (emtricitabine and tenofovir alafenamide), Gilead’s Third TAF-Based HIV Therapy
Sep  2, 2015Gilead’s Investigational Fixed-Dose Combination of Emtricitabine/Tenofovir Alafenamide (F/TAF) Meets Primary 48-Week Objective in Phase 3 Study
Apr  7, 2015Gilead Submits NDA to FDA for Fixed-Dose Combination of Emtricitabine/Tenofovir Alafenamide for HIV

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