Indian generic HIV jab costing 40 dollars a year wins tentative clearance from US regulator
The Dr. Reddy's product, a copy of Gilead's lenacapavir, is injected twice a year and is intended for 120 low- and middle-income countries.
The US Food and Drug Administration has granted tentative approval to the first generic version of lenacapavir, an injection given twice a year to prevent HIV infection. The product was developed by India's Dr. Reddy's Laboratories with support from Unitaid, the Clinton Health Access Initiative and Wits RHI at the University of the Witwatersrand, Unitaid reports. The approval is tentative because Gilead's original is still under patent, the AP news agency explains; that status nevertheless allows the US government to procure the product.
The price is 40 dollars per person per year, the same as the daily prevention pills currently available, Business Standard writes on the basis of PTI. The product is intended for 120 low- and middle-income countries covered by Gilead's voluntary licence. It may not be sold in the United States, where the brand-name product Yeztugo costs 28,218 dollars a year, according to AP. According to Unitaid, the first supplies should reach countries by the end of 2026, with wider availability in 2027; countries that require their own approval may have to wait longer.
In two studies of people at high risk, lenacapavir almost completely prevented new infections, AP reports. Recipients must test negative for HIV before starting and at each injection. According to Unitaid, more than 125,000 people in ten African countries have already started on the brand-name product. The World Health Organization counted 41 million people living with HIV last year and 570,000 deaths from HIV-related causes; according to advocates, around 20 million people worldwide need preventive medication.