Gilead Sciences Receives the US FDA Advisory Committee’s Recommendation on Approval of Descovy for PrEP

Gilead Sciences Receives the US FDA Advisory Committee’s Recommendation on Approval of Descovy for PrEP

Shots:

  • The US FDA advisory committee voted 16 to 2 for Descovy’s approval to treat proposed indication of pre-exposure prophylaxis (PrEP) in men and transgender women (TGW) who have sex with men
  • The committee reviewed the P-III DISCOVER global trial data assessing Descovy vs Truvada in men and transgender women who have sex with men and are at high-risk for sexually acquired HIV infection and resulted in non-inferiority data, improvement in renal and bone laboratory parameters
  • Additionally, the committee reviewed PK data for HIV and PrEP treatment in cis-gender (not part of DISCOVER study) and voted 10 out of 8 as the data was not adequate in regards to efficacy. Descovy (emtricitabine 200 mg and tenofovir alafenamide 25 mg tablet; F/TAF) is indicated in combination with antiretroviral agents for HIV infection in patients weighing at least 35 kg. The product also has a boxed warning of Post Treatment Acute Exacerbation of Hepatitis B

Click here to­ read full press release/ article | Ref: Gilead | Image: Twitter