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GENDER/ HEALTH/ EDUCATION - November 2026

Nov 2026

Nov 03, 2026

Dr Reddy’s gets USFDA nod for lenacapavir PrEP injection

Dr Reddy’s Laboratories announced tentative USFDA approval for its twice‑yearly lenacapavir injection for HIV PrEP in adults and adolescents weighing at least 35 kg. The approval, under PEPFAR, moves the long‑acting medicine toward use in about 120 countries outside the United States covered by a Gilead‑licence. First supplies are expected before year‑end, with broader access in 2027. Lenacapavir is a first‑in‑class HIV‑1 capsid inhibitor. Gilead granted the licence in 2024; Unitaid, CHAI and Wits RHI support accelerated generic development to reach underserved populations at around $40 per person per year.
  • USFDA tentative approval for lenacapavir PrEP injection.
  • Twice‑yearly long‑acting HIV prevention medicine.
  • Targeted for adults and children ≥35 kg; 120 countries via licence.
  • First supplies expected before end of 2026; full rollout 2027.
  • Support from Unitaid, CHAI and Wits RHI to reduce costs.
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