The US Food and Drug Administration (FDA) has approved an India-made generic version of lenacapavir, a long-acting injection used to prevent HIV, in a development that could improve access to prevention medication in lower-income countries. Lenacapavir is administered twice a year for HIV prevention. The generic version is expected to become available in some countries within weeks, according to the supplied Associated Press report. The approval could help make the medication more affordable and accelerate its availability across 120 low- and middle-income countries. The announcement was made on Monday by the manufacturer and organisations involved in accelerating the development of the generic drug. The FDA approved the medicine under a longstanding process intended to help ensure the quality of HIV-related drugs supplied to other countries through US government programmes. The development is significant because access to HIV prevention medication remains a challenge in many countries, particularly where healthcare resources and affordability are limited. Generic medicines can help expand access by increasing supply and potentially reducing costs. Lenacapavir’s twice-yearly dosing also offers an alternative to prevention methods that require more frequent administration, potentially making HIV prevention easier for some people. However, approval does not automatically mean the medicine will immediately be available in every country. Local regulatory requirements, distribution arrangements, pricing and healthcare access will influence when it reaches patients. The supplied report does not identify the manufacturer, expected pricing or specific countries where the generic will first become available.

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