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FDA tentatively approves generic twice-yearly HIV prevention shot
The Associated Press reported Monday that the FDA tentatively approved a generic of Gilead's twice-yearly HIV prevention shot lenacapavir for use in 120 lower-income countries, not the U.S.
- New headline Was: “Approval of a cheap version of HIV-prevention shot lenacapavir raises hopes in low-income countries”
- Our desk filed its story
Based on reporting by AP
The U.S. Food and Drug Administration on Monday issued a tentative approval for a generic form of lenacapavir, a twice-yearly injection used to prevent HIV, according to the Associated Press, which said the step is meant to support cheaper supply in 120 low- and middle-income countries1.
AP said the generic is expected to cost about $40 per person per year where it will be sold, matching the price of daily oral PrEP, and that manufacturer and partner groups announced the approval Monday morning1. The wire said Gilead Sciences' branded product Yeztugo, approved last year, remains under U.S. patent and cannot be sold as this generic in the United States, with a U.S. list price of $28,218 a year before insurance1.
AP reported the FDA used a longstanding pathway for HIV medicines supplied abroad by the U.S. government, and that a U.S. approval can speed reviews elsewhere1. Gilead had been the only supplier, the story said, and last year signed royalty-free licenses with six generic makers covering specified countries in sub-Saharan Africa, Asia and Latin America1. A Gilead spokesperson, quoted by AP, said the company shares urgency about expanding prevention access and believes it has enabled a fast, sustainable path for the most affected communities1.
The generic was developed by India's Dr. Reddy's Laboratories under an agreement involving Unitaid, the Clinton Health Access Initiative and Wits RHI, AP said1. WHO figures cited in the report put 41 million people living with HIV and 570,000 HIV-related deaths last year1. Partners told AP some supply could start within weeks, though other countries' own reviews may take longer, other manufacturers' generics are not yet FDA-approved, and purchase funding still has to be lined up1.
