GSK has expanded its voluntary licensing agreement with the United Nations-backed Medicines Patent Pool (MPP) for cabotegravir, allowing it to be produced by three generic drugmakers and supplied to patients in poorer nations for HIV treatment.
The adjustment comes the same day that the World Health Organization (WHO) updated its guidance, recommending the long-acting injectable combo treatment of Cabenuva, or cabotegravir and rilpivirine, as an alternative to daily oral therapy for patients who are virally suppressed.
Rilpivirine, which was developed by Johnson & Johnson and is known commercially in its oral formulation as Edurant, was approved by the FDA as an HIV treatment in 2011 and already has generic versions available outside the U.S.
“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,” Meg Doherty, the director of the WHO’s global HIV, hepatitis and STI programs, said in a release.
The agreement comes on top of a licensing deal in 2022, which allowed specified generic drugmakers to produce their versions of cabotegravir for pre-exposure prophylaxis (PrEP). The long-acting drug, injected every two months, earned an FDA approval in 2021 under the brand name Apretude as a single agent for HIV prevention.
The MPP licensing deal allows generic drugmakers Aurobindo, Cipla and Viatris to produce and supply their version of the treatment to all countries in Sub-Saharan Africa, as well as those in the world classified as low-income and lower-middle-income. The deal covers 133 nations.
“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,” Charles Gore, the executive director of the MPP, added in a release.
The agreement comes a week after Gilead signed on to provide its newly approved long-acting, injected PrEP drug Yeztugo at a not-for-profit rate to poorer nations around the world. The deal was struck with the Global Fund to Fight AIDS, Tuberculosis and Malaria and is designed to provide coverage for up to 2 million people over three years. Before that, Gilead had inked agreements with six generic drug manufacturers to make and sell Yeztugo across 120 high-incidence, resource-limited countries.
Last month, the FDA signed off on Yeztugo as a twice-yearly alternative to Apretude.