Generic lenacapavir HIV prevention shot wins US FDA approval
The FDA has approved a generic version of lenacapavir, a twice-yearly HIV prevention injection, potentially clearing a regulatory hurdle for lower-cost supplies in low- and middle-income countries.
The Food and Drug Administration (FDA) has given provisional approval for a generic version of a groundbreaking HIV prevention medicine, potentially expanding access to lower- and middle-income countries. The drug, created by Dr. Reddy’s Laboratories, is expected to roll out next month as part of a collaborative initiative driven by several global health organizations.
The annual cost per patient will be $40, which is comparable to the cost of daily oral medication. The injectable drug, termed lenacapavir, is considered a game-changer in the fight against HIV due to its nearly complete protection against the virus with just one injection every six months. The brand-name counterpart, Yetzugo, is marketed by Gilead Sciences and received FDA approval in the previous year.
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