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