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FDA Approves Generic HIV Prevention Shot, Aiming for Global Access
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In Short: Dr Reddy received financial, technical, and regulatory support from Unitaid, Wits RHI, and the Clinton Health Access Initiative (CHAI) to accelerate the development of the generic.
The US Food and Drug Administration (FDA) has approved the first generic version of lenacapavir, a highly effective twice-yearly injection to prevent HIV, developed by Dr Reddy’s Laboratories based in India.
The approval, which came just 16 months after Gilead’s product was approved, is part of an effort to ensure the drug becomes available in lower-income countries as quickly as possible.
CHAI CEO Dr Neil Buddy Shah said, “Getting a generic approved just 16 months after the originator approval for prevention, rather than a decade later, shows what’s possible when we prioritize access from the start. This should be the new standard for global health.”
The generics are expected to cost $40 a year for the two injections and are projected to reach countries by the end of this year, with initial supplies expected to reach a few low-income countries by the end of 2026.
Unitaid’s early risk-taking is helping shorten the time between a scientific breakthrough and real access in countries, according to Dr Philippe Duneton, Unitaid executive director.
Dr Reddy received financial, technical, and regulatory support from Unitaid, Wits RHI, and the Clinton Health Access Initiative (CHAI) to accelerate the development of the generic.
Countries need health systems that are ready to deliver new prevention options, providers who are confident in offering them, and communities that are engaged as partners in their introduction and scale-up. Bringing these elements together will be critical to ensuring equitable access and impact.
Unitaid, Wits RHI, and CHAI are working with governments, communities, the Global Fund, the US Bureau of Global Health Security and Diplomacy (GHSD), the Gates Foundation, and other partners to turn approval into access on the ground, from supporting country introduction and community engagement to generating real-world evidence to inform how lenacapavir can best reach diverse and underserved populations.
Background
The FDA has approved a generic version of the HIV prevention drug lenacapavir, marking a significant step in expanding access to the medication in lower-income countries.
What's confirmed
- The agreement, signed in October 2024, limits the sale of the generics to 120 high-incidence, resource-limited countries.
- The company, one of the world’s largest generic drugmakers, plans to start shipping the medicine next month as part of an effort propelled, in part, by several global health organizations to ensure the drug becomes available in lower-income countries as quickly as possible.
What's still developing
- German startup Isar Aerospace on Sunday said it would rapidly expand satellite deployments after the first orbital launch of its Spectrum rocket from Arctic Norway, a milestone for Europe’s efforts to secure independent access to space.
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