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FDA Approves Generic HIV Prevention Shot, Aiming to Expand Access in Lower-Income Countries
· Confirmed
In Short: The FDA has approved the first generic version of lenacapavir, developed by Dr Reddy’s Laboratories, to prevent HIV, aiming to widen access in lower-income countries.
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. This approval marks a significant step in expanding access to the medication in lower-income countries, where the drug is expected to cost just $40 a year for the two injections.
Dr Reddy’s Deepak Sapra described the approval as “a moment of immense pride” for the company.
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.” Dr Reddy’s received “financial, technical, and regulatory support” from Unitaid, Wits RHI, and the Clinton Health Access Initiative (CHAI) to accelerate the development of the generic.
Jessica Burry, a technical officer at Unitaid, said, “There are some countries who would be able to fast-track regulatory approvals based on a reliance mechanism on the US FDA.” The broader rollout of the drug across eligible countries is expected in 2027, according to Dr Reddy’s. Unitaid’s early risk-taking is helping shorten the time between a scientific breakthrough and real access in countries, said Dr Philippe Duneton, Unitaid executive director.
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, said Health Policy Watch. 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.
India's imports from EFTA countries last year were at $32.4 billion, most of which were from Switzerland, which accounted for a third of that number, according to BBC. Both the Section 301 investigation on New Delhi and the trade deal have resulted in a convergence between the countries, said The Indian Express.
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.
The US Food and Drug Administration has approved the first generic version of lenacapavir, developed by Dr Reddy’s Laboratories, to prevent HIV, aiming to widen access 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.
- "There are some countries who would be able to fast-track regulatory approvals based on a reliance mechanism on the US FDA," said Jessica Burry, a technical officer at Unitaid, adding that the approval could also help accelerate procurement.
- 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.
- Iran’s central military command said in a statement on Sunday that it had received information that the United States, with the backing of some regional countries, was preparing to resume military actions against it, state media reported.
What's still developing
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- The Media Line is on the ground in 12 Middle Eastern countries.
- Only the U.S. voted against it while six other countries — Serbia, Estonia, Georgia, Lithuania, Moldova and Ukraine — abstained.
- “Outside of that very narrow navigation application, there is no point in using it,” according to Mark Monmonier, a Syracuse University professor of geography. 24/7 coverage of breaking news and live events The United Nations General Assembly on Friday endorsed a new world map that represents Africa more accurately in its larger size, a culmination of a recent campaign led by African countries and advocacy groups.
- Our growing network of journalists in Africa, Asia, Geneva and New York connect the dots between regional realities and the big global debates, with evidence-based, open access news and analysis.
- The FDA approval comes only 16 months after Gilead’s product was approved.
- The statement said that any US attack would trigger sustained strikes on US bases and interests in the region, warning that regional countries supporting US aggression against Iran would be considered parties to the conflict.