Overview
- The FDA issued tentative approval for a Dr. Reddy’s generic of lenacapavir, a twice‑yearly injectable PrEP, a decision announced on Monday that certifies the product’s quality for export but does not allow U.S. sales while the branded drug remains under patent.
- Partners expect the generic to be priced at about USD 40 per person per year in the targeted countries, a sharp cut from the branded U.S. list price of roughly USD 28,000 and designed to expand access to people who need PrEP.
- Dr. Reddy’s development was accelerated under voluntary licensing from Gilead and technical and financial support from Unitaid, CHAI and Wits RHI, with the review completed in about 16 months.
- Clinical trials show lenacapavir given every six months provided near‑complete protection in people without HIV, but programs require HIV testing before each injection because undiagnosed infection can lead to drug resistance; common side effects include injection‑site reactions, headache and nausea.
- Shipments are expected to begin late 2026 with Zambia among early recipients, yet broader rollout depends on national registrations, procurement funding, approvals for other licensed generic manufacturers and the strengthening of delivery and monitoring systems.