Gilead Sciences has received FDA approval for Bixlenvo, a once-daily pill for adults with suppressed HIV, combining bictegravir from its blockbuster Biktarvy with lenacapavir, the foundation of its long-term HIV strategy. The drug aims to simplify treatment for patients on complex multi-pill regimens, which represent only about 5% of people living with HIV in the United States. In two late-stage studies, Bixlenvo matched the effectiveness of existing regimens at maintaining viral suppression after 48 weeks. Gilead expects the drug to be available within days, with a wholesale acquisition cost of $4,595 for a 30-day supply. However, the eligible market is narrow, and patients must complete an initial two-day dose of Sunlenca before starting Bixlenvo, while facing competition from Merck's recently approved Idvynso.
Gilead Sciences IncFDA approval for Bixlenvo, a new HIV drug, expands Gilead's product portfolio.
Merck & Company IncMerck's recently approved Idvynso is mentioned as a competitor to Gilead's Bixlenvo.
Merck KGaA