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October 1, 2025
Generic Access to Lenacapavir Will Save Millions in Low-Income Countries
By IDSE News Staff
A new partnership announced today between the Gates Foundation and Indian manufacturer Hetero Labs—supported by up-front funding and volume guarantees—will enable the company to manufacture generic lenacapavir at roughly $40 per patient per year (after a short pretreatment oral regimen), a price point designed to make the breakthrough treatment affordable for national health systems.
“Hetero is pleased to partner with the Gates Foundation to create a pathway for the sustainable and affordable supply of lenacapavir,” said Vamsi Krishna, PhD, the managing director of Hetero Group of Companies. “This collaboration reflects our commitment to ensuring access to innovative HIV medicines for patients in India and other low- and middle-income countries.”
In a parallel move, Unitaid, the Clinton Health Access Initiative, and Wits RHI announced new commitments with Dr. Reddy’s Laboratories Ltd. (DRL), another Indian manufacturer, reinforcing efforts to build a competitive generics ecosystem. The accelerated development of a large-scale generic supply of lenacapavir, which is anticipated as early as 2027 pending regulatory approval, will reduce the time between initial doses and provide wider access to the drug. This move could potentially transform the fight against HIV and help end the epidemic faster and more equitably.
The new collaborations complement present agreements between the Global Fund to Fight AIDS, Tuberculosis and Malaria, Gilead Sciences, and the U.S. Department of State through PEPFAR (the U.S. President’s Emergency Plan for AIDS Relief) and supported by the Children’s Investment Fund Foundation (CIFF), to roll out the initial supply of lenacapavir in LMICs, potentially reaching countries as early as the end of 2025.
Lenacapavir offers six months of protection with a single injection. Public health experts see it as a transformative option for people who face barriers to daily oral PrEP, including stigma, adherence challenges, and inconsistent access to medication.
Continue reading... https://www.idse.net/HIV-AIDS/Article/10-25/HIV-Lenacapavir-Generic-Access/78428
CONTACT
Marie Rosenthal
MRosenthal@McMahonmed.com
"Reproduced with permission - Infectious Disease Special Edition (IDSE)"
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