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 long-acting injectable for HIV prevention, lenacapavir, just 16 months after the originator product's approval. This rapid approval, supported by a novel regulatory strategy and collaborations, aims to make an affordable, twice-yearly HIV prevention option available in 120 low- and middle-income countries, with initial supplies expected by the end of 2026.