GSK Expands Agreement with Medicines Patent Pool for Generic Production of Cabotegravir

GSK has broadened its voluntary licensing agreement with the United Nations-backed Medicines Patent Pool (MPP) for cabotegravir, a move that will allow three generic drugmakers to produce and supply the HIV treatment to patients in low- and middle-income countries. This expansion comes on the heels of updated guidance from the World Health Organization (WHO) recommending long-acting injectable treatments as an alternative to daily oral therapy for virally suppressed patients.

Expanded Access to Long-Acting HIV Treatment

The agreement permits Aurobindo, Cipla, and Viatris to manufacture and distribute generic versions of cabotegravir to 133 nations, including all countries in Sub-Saharan Africa and those classified as low-income and lower-middle-income. This development builds upon a 2022 licensing deal that focused on cabotegravir for pre-exposure prophylaxis (PrEP).

Meg Doherty, director of WHO's global HIV, hepatitis, and STI programs, emphasized the alignment of this move with recent WHO recommendations, stating, "This step is closely aligned with WHO's new recommendation of long-acting injectable antiretrovirals as an alternative for people who are virologically suppressed but face adherence challenges with daily oral regimens."

Charles Gore, executive director of the MPP, highlighted the importance of this expansion, noting, "Expanding access to long-acting options like this supports a more person-centered, choice- and needs-driven approach, which is exactly what an equitable and effective HIV response requires."

Industry-wide Efforts to Improve HIV Treatment Access

GSK's agreement expansion is part of a broader industry trend to increase access to long-acting HIV treatments and prevention methods. Recently, Gilead Sciences partnered with the Global Fund to Fight AIDS, Tuberculosis and Malaria to provide its newly FDA-approved long-acting, injected PrEP drug Yeztugo at a not-for-profit rate to resource-limited countries. This initiative aims to cover up to 2 million people over three years.

Additionally, Gilead has established agreements with six generic drug manufacturers to produce and sell Yeztugo across 120 high-incidence, resource-limited countries. The FDA approved Yeztugo last month as a twice-yearly alternative to GSK's Apretude, which is administered every two months.

These developments underscore the pharmaceutical industry's ongoing efforts to address global health disparities and improve access to innovative HIV treatments and prevention methods in resource-limited settings.