FDA tentatively approves generic lenacapavir

The twice-yearly injection could expand access to affordable HIV prevention across 120 countries.

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The FDA tentatively approved Dr. Reddy’s generic lenacapavir injection for HIV pre-exposure prophylaxis in adults and adolescents weighing at least 35 kg.
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Tentative approval does not permit US marketing while applicable patent protections remain in effect, but may accelerate regulatory reviews in 120 participating low- and middle-income countries.
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Under the partnership agreement, the injectable formulation is priced at $40 per person annually, and the required initial oral loading course costs up to $17.
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In PURPOSE 1 and PURPOSE 2, twice-yearly lenacapavir reduced HIV incidence by 96% versus estimated background incidence and by 89% versus daily oral PrEP.
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The efficacy findings concern Gilead’s original formulation, not a separate trial of the generic; lenacapavir labeling warns of resistance with undiagnosed HIV and requires testing before initiation a

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