
The generic injection, developed by Indian pharmaceutical company Dr. Reddy’s Laboratories, is expected to expand access to long-acting HIV prevention, particularly in countries where the cost of newer prevention technologies remains a barrier.
The United States Food and Drug Administration (FDA) granted approval for the generic version following financial, technical and regulatory support from Unitaid, the Wits Reproductive Health and HIV Institute (Wits RHI) and the Clinton Health Access Initiative (CHAI).
Under a partnership agreement combining early pricing commitments with financial and technical assistance, Dr. Reddy’s Laboratories is expected to supply the injection at an annual cost of US$40 per person across 120 countries covered by Gilead Sciences' voluntary licensing arrangement.
Uganda is among the eligible countries.
Lenacapavir is a long-acting injectable pre-exposure prophylaxis (PrEP) administered twice a year to prevent HIV infection. It offers an alternative to daily oral prevention medication, particularly for people who face challenges adhering to daily pill-taking.
Commenting on the development, Unitaid Executive Director Dr Philippe Duneton said early investments and risk-taking by partners were helping shorten the time between scientific breakthroughs and access to medicines in low- and middle-income countries.
The development is expected to strengthen efforts to expand access to HIV prevention, although the actual availability of the generic injection in Uganda will depend on regulatory approval and procurement arrangements.
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