FDA tentative approval: lenacapavir at $40 a year in 120 countries

The FDA's tentative approval of a generic lenacapavir comes as some of the world's poorest countries are reeling from Western aid cuts. Washington's funding cuts to some HIV-prevention programs in Africa left efforts there floundering, sparking fears that the continent could see hundreds of thousands of additional deaths from AIDS. Against that backdrop, the move to make the twice-a-year injection available for $40 per person a year in 120 low- and middle-income countries is seen as a potential lifeline. A global health advocate said a large-scale rollout of the affordable drug could help “bring an end to the HIV epidemic,” suggesting the approval may be most significant for how it enables broad access rather than for the drug's clinical profile alone.