Washington Approves Low-Cost Alternative for Groundbreaking AIDS Treatment in Poor Countries - Sarmad

The U.S. Food and Drug Administration (FDA) approved on Monday a low-cost version of an injectable HIV prevention shot administered twice a year, bringing this leading drug closer to markets in low-income countries.

The preliminary approval was announced by Indian company Dr. Reddy’s Laboratories, which manufactures the generic version of lenacapavir, alongside the global health initiative Unitaid.

This generic version will be available at a cost of $40 per person annually in 120 countries, under a pricing agreement announced in September 2025 between Unitaid, the Wits Health Research Institute (Wits RHI) in Africa, the Clinton Health Access Initiative (CHAI), and Dr. Reddy’s Laboratories.

Lenacapavir was originally developed by U.S. pharmaceutical company Gilead Sciences and received approval in June 2025 after demonstrating efficacy exceeding 99.9% in large-scale clinical trials.

In a statement to Agence France-Presse, Carmen Perez-Casas, Head of HIV Strategy and Pandemic Preparedness at Unitaid, said, “This is an exceptional achievement for global health. For far too long, people in low- and middle-income countries have had to wait a decade or more to access leading drugs available elsewhere.”

She added, “With lenacapavir, we have succeeded in narrowing this gap to just over one year. Providing an FDA-approved generic version at $40 per person annually—a price comparable to the cost of daily pills for HIV prevention—represents a remarkable achievement.”

This twice-yearly injectable drug, which resembles a vaccine in its mode of administration though it does not train the immune system, could offer a more effective means of providing pre-exposure prophylaxis (PrEP) against the virus compared to daily pills. Daily pills were first approved in the United States in 2012, but their effectiveness relies entirely on consistent adherence.

However, the high cost of lenacapavir, approximately $28,000 annually in the United States, has been a major barrier to its transformation into a key tool in combating the disease, which has claimed more than 40 million lives over four decades.

In late 2024, Gilead granted voluntary licenses to produce lenacapavir to six generic drug manufacturers, including Dr. Reddy’s Laboratories.

A statement from Unitaid noted that even before the availability of lenacapavir generics produced by Gilead, more than 125,000 people in 10 African countries, which were among the first to adopt the drug, had already begun using it.

Deepak Sabra, Chief Executive Officer of Pharmaceutical Services and Active Pharmaceutical Ingredients at Dr. Reddy’s Laboratories, said in a statement, “This is a moment of great pride for all of us at Dr. Reddy’s.”

Unitaid clarified that the generic version of the drug received “preliminary approval” from the FDA under an expedited pathway that allows advanced entities to leverage existing data.