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Jump to Key Points Nov 2 (Reuters) - Dr Reddy's said on Monday that the US FDA has tentatively approved a generic version of a new and highly effective HIV prevention drug, paving the way for sales in many low- and middle-income countries, though not yet in the United States.
Some doctors and activists say the new treatment could help control the 44-year-long AIDS epidemic which still infects 1.3 million people a year, and which the World Health Organization estimates has killed 44 million since it first emerged.
The generic manufacturer was the first of six licensed by Gilead Sciences to get tentative Food and Drug Administration approval for the drug, potentially accelerating access in 120 low- and middle-income countries covered by licensing agreements.
FDA tentative approval is given to drugs that meet all the agency's safety, efficacy and quality standards but cannot yet be sold in the US due to patent or exclusivity issues.
- Dr Reddy's received tentative FDA approval for generic lenacapavir.
- Approval enables access in 120 LMICs via licensing agreements.
- Not yet marketable in US; patent/exclusivity remain limiting.
- Twice-yearly injectable lenacapavir showed near-100% efficacy in trials.
- Generic price expected ~$40/year vs ~$28,000 branded Yeztugo.
The approval could help speed the rollout by allowing global procurement agencies and some national regulators to rely on the FDA assessment when making purchasing and approval decisions.
"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.
Initial supplies of the twice-yearly lenacapavir injection are expected to reach a few low-income countries by the end of 2026, Burry said.
Unitaid, a global health agency hosted by the World Health Organization, is providing technical and financial support to Dr Reddy's on the project, alongside the Clinton Health Access Initiative and Wits Reproductive Health and HIV Institute, which is part of South Africa's University of the Witwatersrand.
Zambia could be one of the first countries to receive the drug, Unitaid said.
Lenacapavir, developed by Gilead Sciences and approved earlier this year for HIV prevention under the brand name Yeztugo, was nearly 100% effective in large trials.
Dr Reddy's generic version is expected to be priced at $40 per year, global health agencies said in a joint statement, compared with about $28,000 for branded Yeztugo in the US.
The broader rollout of the drug across eligible countries is expected in 2027, said Dr Reddy's.
Separately, Indian drugmaker Hetero is working with the Gates Foundation on lenacapavir.
(Reporting by Rishika Sadam in Hyderabad and Jennifer Rigby in London; Editing by Alexander Smith)
