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FDA Approves Generic Version of HIV-Prevention Drug to Be Sold in Low-Income Countries
The tentative approval could speed access to the twice-yearly HIV prevention shot, which is expected to cost about $40 a year per person.
The Food and Drug Administration approved a generic version of the twice-a-year HIV prevention shot for use in 120 low- and middle-income countries, marking a significant step toward expanding global access to lenacapavir.
Generic lenacapavir remains unavailable domestically because the brand-name version, Yeztugo, made by Gilead Sciences, is protected by patent; Yeztugo costs $28,218 annually while the generic is expected to cost $40.
India-Based Reddy Laboratories developed the generic through an agreement brokered by Unitaid, the Clinton Health Access Initiative, and Wits RHI, aiming to accelerate development and reduce costs.
The Food and Drug Administration granted 'tentative' approval, a standard designation for generics while patents exist; Carolyn Amole of the Clinton Health Access Initiative said, 'We could help to scale this to the 20 million people around the world who need PrEP.'
According to the WHO, 41 million people worldwide were living with HIV last year and 570,000 died from HIV-related causes; advocates believe this medication will ultimately help drive down new HIV and AIDS cases.
The FDA approved a generic HIV preventive injection, facilitating its access in low-income countries, reducing transmission risk by 99.9%.Treatment, at $40 a year, will be available in 120 nations, thanks to an agreement between Dr. Reddy's, Unitaid and others, marking a milestone in the fight against HIV.
The U.S. Food and Drug Administration (FDA) has approved a generic version of the world's only six-monthly injection to prevent HIV, which means that...