FDA approval announcements and updates

Lenacapavir Named 2024 Breakthrough for HIV Prevention with Six-Month Injection Amid Cost Concerns

Dec 12, 2024, 08:05 PM

The injectable drug lenacapavir, developed by Gilead Sciences, has been named Science's 2024 Breakthrough of the Year for its remarkable efficacy in preventing HIV infection. Administered every six months as a subcutaneous injection, lenacapavir demonstrated 100% effectiveness in clinical trials with adolescent girls and women in Africa and 99.9% efficacy in trials involving diverse populations across continents. The drug works by targeting and stiffening the capsid protein of HIV, blocking key stages of virus replication. Despite its potential to significantly reduce global HIV infection rates, concerns have emerged about its high cost, with estimates ranging from $25,395 to $44,918 annually per patient. While Gilead has partnered with generic manufacturers to produce low-cost versions for 120 low-income countries, middle-income nations like Brazil are excluded from this agreement, raising accessibility challenges. Regulatory approval is anticipated by 2025, with availability expected by 2026. UNAIDS has highlighted the importance of ensuring equitable access to this groundbreaking prevention tool.