Gilead Sciences Submits sNDA with Priority Review Voucher to Expand Descovy’s Use for HIV Pre-Exposure Prophylaxis (PrEP)

Recently, Gilead Sciences, Inc. announced that it has submitted a supplemental new drug application to the U.S. FDA for the use of Descovy in pre-exposure prophylaxis (PrEP) therapy to reduce the risk of HIV infection among HIV-negative individuals. The company utilized a priority review voucher for this application, indicating that approval is expected within six months.FDAresponse. Expanding the indications for Descovy to include PrEP therapy is a key R&D objective for Gilead Sciences in the field of HIV/AIDS. The use of a Priority Review Voucher indicates the company’s effort to bring Descovy as a PrEP regimen to populations at risk of HIV infection as soon as possible.

AIDS is an infectious disease caused by HIV infection. The development of modern antiretroviral drugs and the rise of "cocktail therapy" have enabled patients with HIV to control the condition long-term and achieve a life expectancy comparable to that of the general population. Recent studies have found that taking antiretroviral drugs before exposure can reduce the risk of HIV infection. This preventive approach is known as PrEP (Pre-Exposure Prophylaxis).

Descovy, developed by Gilead Sciences, Inc., is a combination tablet composed of emtricitabine and tenofovir alafenamide. It has been approvedFDAApproved for use in combination with other antiviral agents to treat patients with HIV infection. In the randomized, double-blind, Phase 3 DISCOVER trialClinical TrialIn China, populations at risk of HIV infection receive PrEP treatment with either Descovy or Truvada. Truvada is the previous-generation antiretroviral drug developed by Gilead Sciences, Inc., and has already obtainedFDAApproved for PrEP treatment against HIV.

Trial results showed that the average annual HIV incidence rate was 0.16 per 100 person-years in the Descovy group and 0.34 per 100 person-years in the Truvada group. Descovy met the criteria for non-inferiority compared with Truvada. Meanwhile, bone mineral density and renal safety profiles were significantly more favorable in the Descovy group than in the Truvada group.

“Previous data have shown that, when used in combination with other medications to treat patients with HIV, Descovy demonstrated superior efficacy and a better safety profile regarding renal function and bone mineral density compared with Truvada. The results of the DISCOVER trial suggest that Descovy can provide similar benefits when used for the prevention of HIV infection, which is an important consideration for populations requiring long-term PrEP therapy,” said Dr. John McHutchison, Chief Scientific Officer and Head of Research and Development at Gilead Sciences, Inc. “We look forward to working withFDA"Complete the review collaboratively to bring this treatment option to populations at risk of HIV infection."BioonBioon.com）