FDA tentatively backs generic HIV shot at $40 a year for 120 countries

The FDA has handed a tentative approval to a generic version of lenacapavir, the twice-a-year injection that guards against HIV. The green light opens the door to a price tag of $40 per person annually across 120 low- and middle-income countries, according to the Associated Press.

That's a striking number for a drug in this class, and it lands at a moment when HIV prevention in some of the world's poorest countries is wobbling. Cuts to Western aid have left programs scrambling, and the fear hanging over the continent is grim: hundreds of thousands of additional AIDS deaths if the money doesn't come back.

A cheap, long-acting shot changes the math. Two doses a year is a far lighter lift than daily pills, and at $40 a head it's suddenly plausible to reach people at scale rather than in pilot pockets.

One global health advocate told the AP the large-scale rollout could help bring an end to the HIV epidemic. That's the ambition — and the test will be whether the supply, the distribution and the funding follow the approval.

Tentative approval is not the same as a full US sign-off, but for the countries in line for the discounted price, it's the signal they've been waiting on.