A lower-cost version of the twice-yearly HIV prevention injection lenacapavir has received tentative approval from the United States Food and Drug Administration, moving it closer to distribution in 120 low- and middle-income countries.
Indian manufacturer Dr Reddy’s Laboratories secured the approval announced Monday, November 2. Under a pricing agreement with global health partners, the generic will be offered at US$40 per person annually. Initial supplies are expected before year-end, followed by wider availability in 2027.
Developed originally by Gilead Sciences, lenacapavir showed nearly complete protection against HIV in major clinical trials. Administered every six months, it provides a prevention option for people who may struggle to take daily pre-exposure prophylaxis, commonly called PrEP.
The generic’s annual price would be substantially below the branded drug’s US list price of approximately US$28,000. However, tentative approval does not permit generic sales in the United States while patent or exclusivity restrictions remain in place.
Dr Reddy’s developed the product with financial, technical and regulatory support from Unitaid, Wits RHI and the Clinton Health Access Initiative.
The partners say the regulatory milestone can help countries advance their own approval processes. Successful introduction will also require prepared health services, trained providers and community involvement.
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