GENEVA, Switzerland | November 10, 2026 | The US Food and Drug Administration (FDA) has granted tentative approval to the first generic version of lenacapavir, a highly effective HIV-prevention injection that requires only two doses a year, opening the way for a significantly cheaper option for millions of people in low- and middle-income countries.
Developed by Indian pharmaceutical company Dr. Reddy’s Laboratories with support from international health organizations, the generic drug is expected to cost approximately US$40 per person annually, compared with the tens of thousands of dollars charged for the branded version in the United States.
The November 2 announcement marks a major step toward expanding access to HIV prevention in 120 low- and middle-income countries covered by licensing agreements with Gilead Sciences, the American pharmaceutical company that developed the original drug. Initial supplies are expected to reach some countries before the end of 2026, with broader availability anticipated in 2027, according to Unitaid and the Clinton Health Access Initiative.
Lenacapavir, marketed under the brand name Yeztugo, is a long-acting injectable medication that prevents HIV infection by targeting the virus’s capsid, the protein shell that protects its genetic material. Unlike conventional pre-exposure prophylaxis (PrEP), which generally requires daily medication, lenacapavir is administered twice yearly.
Clinical trials have demonstrated exceptionally high protection against HIV infection. Results from Gilead’s PURPOSE 1 and PURPOSE 2 studies showed that the injection reduced the risk of acquiring HIV by approximately 96% to 100% among participants, making it one of the most significant developments in HIV prevention in recent years.
The original version received US FDA approval in June 2025. The approval of Dr. Reddy’s generic version just 16 months later represents an unusually rapid transition from an innovative medicine to a lower-cost alternative.
The accelerated development involved Unitaid, the Clinton Health Access Initiative and the Wits Reproductive Health and HIV Institute in South Africa, which provided financial, technical and regulatory assistance. Gilead had previously granted voluntary, royalty-free licenses to six generic manufacturers to produce the medication for designated countries.
However, international health advocates have cautioned that regulatory approval does not automatically guarantee access. Doctors Without Borders, also known as Médecins Sans Frontières, noted that 26 low- and middle-income countries remain excluded from the licensing arrangements, including countries in Latin America with growing HIV epidemics.
The organization has called on Gilead to expand its licensing agreements so that more countries can benefit from affordable generic supplies.
According to the World Health Organization, approximately 41 million people were living with HIV worldwide in 2025, while an estimated 570,000 people died from HIV-related causes during the same year, underscoring the continuing need for more accessible prevention and treatment services.
The United Nations Programme on HIV/AIDS (UNAIDS) previously reported that approximately 1.3 million people acquired HIV in 2024, significantly exceeding the global target of reducing new infections to 370,000 by 2025.
The introduction of affordable lenacapavir could help address persistent barriers to HIV prevention, particularly among vulnerable communities, young women and people who face difficulties accessing daily medication. However, health organizations stress that countries will still need regulatory clearance, adequate funding, reliable supply chains and trained healthcare workers to distribute the injections safely.
For developing countries, the breakthrough represents an important opportunity to make advanced HIV prevention more accessible. Its success, however, will depend on whether governments and international partners can translate the lower price and regulatory approval into actual availability for the people who need it most.
Si Venus L Peñaflor ay naging editor-in-chief ng Newsworld, isang lokal na pahayagan ng Laguna. Publisher din siya ng Daystar Gazette at Tutubi News Magazine. Siya ay isa ring pintor at doll face designer ng Ninay Dolls, ang unang Manikang Pilipino. Kasali siya sa DesignCrowd sa rank na #305 sa 640,000 graphic designers sa buong daigdig. Kasama din siya sa unang Local TV Broadcast sa Laguna na Beyond Manila. Aktibong kasapi siya ng San Pablo Jaycees Senate bilang isang JCI Senator.
- Venus L Peñaflor
- Venus L Peñaflor
- Venus L Peñaflor
- Venus L Peñaflor
