Gilead’s Descovy Receives the US FDA’s Approval for HIV Pre-Exposure Prophylaxis 

 Gilead’s Descovy Receives the US FDA’s Approval for HIV Pre-Exposure Prophylaxis 

Gilead Descovy Receives the US FDA’s Approval for HIV Pre-Exposure Prophylaxis

Shots:

  • The US FDA’s approval is based on P-III DISCOVERY study assessing Descovy (emtricitabine, 200mg and tenofovir alafenamide, 25mg) vs Truvada (emtricitabine, 200mg and tenofovir disoproxil fumarate, 300mg tablets) in 5,387 in people weighing at least 35kg  in a ratio (1:1) at risk for sexually acquired HIV
  • The P-III DISCOVERY study demonstrated non-inferiority to Truvada with high efficacy with statistically significant improvements in renal and bone safety. The sNDA of Descovy is approved under PR designation
  • Descovy is indicated to reduce the risk of sexually acquired HIV-1 infection in adults and adolescents weighing at least 35 kg who are HIV-negative and at risk for sexually acquired HIV, excluding individuals at risk from receptive vaginal sex. The product also has a boxed warning for the risk of post-treatment acute exacerbation of hepatitis B

Click here to­ read full press release/ article | Ref: Gilead | Image: Investor’s Business Daily

Vartika Singh

Vartika Singh is a content writer who loves to write research articles and reports at PharmaShots. She has in-depth knowledge of the life sciences industry including the Pharma and Biotech sectors. Any articles written by her can be contacted at connect@pharmashots.com.

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