Home / Health / HIV Prevention Drug Gets Green Light for Low-Income Nations
HIV Prevention Drug Gets Green Light for Low-Income Nations
2 Nov
Summary
- US FDA tentatively approved a generic HIV prevention drug.
- The drug is expected to cost $40 annually in eligible countries.
- Initial supplies could reach some low-income nations by late 2026.
The US FDA has granted tentative approval for a generic version of a new, highly effective HIV prevention drug developed by Dr Reddy's. This approval is significant as it could accelerate access to the treatment in 120 low- and middle-income countries covered by licensing agreements.
This tentative approval allows global procurement agencies and some national regulators to use the FDA's assessment for their own purchasing and approval decisions. Unitaid, a global health agency, has stated that this could enable some countries to fast-track their regulatory processes.
Initial supplies of the twice-yearly injection are projected to reach a few low-income countries by the end of 2026. Zambia is mentioned as a potential first recipient. The broader rollout across eligible countries is anticipated in 2027. The generic version is expected to be priced at around $40 per year, significantly lower than the branded alternative.
