Affordable HIV Prevention Shot Approved for Global Market

The US Food and Drug Administration (FDA) has approved a cheaper version of an HIV prevention shot. This approval, announced on Monday, aims to make the drug more accessible in low-income countries.

The generic version of the shot, called lenacapavir, is produced by Dr. Reddy’s Laboratories, an Indian pharmaceutical company. It will be available for about $40 per person per year in 120 countries, thanks to a pricing agreement made in September 2025 with Unitaid, a global health initiative.

Deepak Sapra, CEO of Dr. Reddy’s Pharmaceutical Services, expressed pride in the achievement, highlighting the effort to create an affordable option for those in need. Philippe Duneton, executive director of Unitaid, noted that this approval helps bridge the gap between scientific breakthroughs and access in various countries.

Lenacapavir was initially developed by Gilead, a US pharmaceutical company, and received FDA approval in June 2025 after showing over 99.9 percent effectiveness in clinical trials. The shot is administered twice a year and is considered a more effective alternative to daily pills for HIV pre-exposure prophylaxis (PrEP).

Before the generic version became available, the cost of lenacapavir in the US was around $28,000 per year, which made it difficult for many to access. However, over 125,000 people in ten African countries have already started using Gilead’s version of the shot.

This approval falls under the FDA’s President’s Emergency Plan for AIDS Relief (PEPFAR) program, which aims to provide treatment and prevention for HIV/AIDS.