Dr Reddy's Laboratories said on Monday, November 2, that the US Food and Drug Administration (USFDA) has granted tentative approval to its long-acting injectable lenacapavir for pre-exposure prophylaxis (PrEP), to reduce the risk of sexually acquired HIV-1 in adults and adolescents weighing at least 35 kg, according to The Hindu BusinessLine.

Source: The Hindu BusinessLine

The approval was granted under the US FDA's President's Emergency Plan for AIDS Relief (PEPFAR) programme. Reuters reported that Dr Reddy's is the first of six manufacturers licensed by Gilead Sciences to receive tentative FDA approval for the drug, potentially accelerating access in the 120 low- and middle-income countries covered by the licensing agreements.

Source: Reuters

$40planned price per person per year in 120 countries
120low- and middle-income countries in the licence
2injections per year
$28,000approx. US price of branded Yeztugo per year, per Reuters

Lenacapavir was developed by Gilead Sciences and approved for HIV prevention in June 2025 after proving nearly 100 per cent effective in large clinical trials, according to Reuters and the Associated Press report carried by Medical Xpress. Gilead markets the original product in the United States as Yeztugo.

The generic programme builds on a voluntary licence Gilead granted Dr Reddy's in October 2024, followed by a September 2025 agreement with Unitaid, the Wits Reproductive Health and HIV Institute (Wits RHI) and the Clinton Health Access Initiative (CHAI) to support development and enable access at $40 per person per year across the licensed countries, The Hindu BusinessLine reported.

What 'tentative approval' means

Tentative approval means the product meets the FDA's safety, efficacy and quality standards but cannot yet be sold in the United States because of patent or exclusivity issues, according to Reuters. It clears the way for supply to the licensed low- and middle-income countries.

Initial supplies of the twice-yearly injection are expected to reach a few low-income countries by the end of 2026, with a broader rollout across eligible countries expected in 2027, according to Dr Reddy's statements reported by Reuters and The Hindu BusinessLine. The partners have cautioned that approval and price alone will not guarantee access — national regulatory approvals and country-level introduction are still needed.