“A decision by U.S. regulators promises to speed the delivery of a powerful HIV prevention tool in low-income countries with high infection rates. The Food and Drug Administration (FDA) today gave its seal of approval to a generic version of injectable lenacapavir, which can protect from HIV infection for 6 months. Its Indian manufacturer, Dr. Reddy’s Laboratories, has pledged to sell the drug for just $40 per person per year, and FDA’s approval is widely expected to lead to licensing in countries where the company is allowed to market it…

Gilead had agreed to provide LEN PrEP at a 'not-for-profit' price to the Global Fund to Fight AIDS, Tuberculosis, and Malaria, which funds disease prevention and treatment efforts in more than 100 countries. (The company has declined to reveal that price, but several sources tell Science it’s $120 per person per year.) It also licensed LEN PrEP to six generic manufacturers, stipulating they could only sell it to 120 low- and lower middle–income countries. Dr. Reddy’s, based in Hyderabad, India, is the first to win FDA approval for its product.”

From Science.