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Generic HIV prevention injection moves closer to 120 countries after FDA approval

NAIROBI, Kenya, Nov 2– Access to a twice-yearly HIV prevention injection is moving closer to millions of people in low- and middle-income countries after Dr. Reddy’s Laboratories secured tentative approval…

Generic HIV prevention injection moves closer to 120 countries after FDA approval

The United States Food and Drug Administration (FDA) has granted tentative approval for a generic version of lenacapavir, an HIV prevention injection, marking a significant milestone in global HIV prevention efforts. This approval, just 16 months after the original product's FDA approval, could lead to the availability of a more affordable long-acting HIV prevention option in 120 low- and middle-income countries by the end of 2026.

The generic version is expected to be priced similarly to oral pre-exposure prophylaxis (PrEP), potentially making it more accessible to individuals at risk of HIV who may find daily preventive pills challenging. Dr. Reddy’s Laboratories secured this regulatory milestone in collaboration with Unitaid, Wits RHI, and the Clinton Health Access Initiative (CHAI), which also played a crucial role in funding and supporting the drug's development and market entry.

Brief written by urgent.news from Capital FM Kenya's own syndicated text. Machine-written — may contain errors; check the original before relying on it.

Also reported by 2 other outlets

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