U.S. FDA Approves First Generic Long-Acting Injectable for HIV Prevention

The U.S. Food and Drug Administration (FDA) has approved the first generic version of lenacapavir, a long-acting injectable for HIV prevention. Developed by Dr. Reddy's Laboratories with support from Unitaid, Wits RHI, and the Clinton Health Access Initiative (CHAI), this approval aims to make an affordable, twice-yearly HIV prevention option available in 120 low- and middle-income countries. This regulatory milestone was achieved through a novel strategy, resulting in one of the fastest timelines to approval for a major HIV innovation.