EU endorsement granted for injectable HIV medication, deemed capable by experts of curtailing transmission
Lenacapavir, a highly effective HIV prevention drug, has received a recommendation for authorization from the European Medicines Agency. Sold as Yeytuo in Europe by Gilead Sciences, this twice-yearly injectable drug is expected to have a wide reach, particularly in low- and middle-income countries with high HIV incidence.
Gilead Sciences' strategic partnerships and licensing agreements aim to ensure the drug's availability in 120 low- and middle-income countries, primarily those with high rates of HIV. The company has signed royalty-free licensing agreements with multiple generic manufacturers to facilitate scalable production of generics, making the drug more accessible and affordable in these regions.
A major partnership with the Global Fund supports distribution, aiming to provide enough doses for up to two million people over the next three years in these countries at no profit to Gilead. The Global Fund's "NextGen Market Shaping" initiative helps keep generics affordable and reduces price erosion, protecting public health interests while maintaining long-term viability for Gilead.
The FDA's approval of lenacapavir in June 2025, coupled with its twice-yearly dosing, positions it as a breakthrough HIV prevention option globally. Pricing strategies include tiered pricing and patient assistance programs in the U.S., and commitments not to profit in vulnerable countries until generics become available.
However, concerns exist about availability and affordability in middle-income countries not covered by the Global Fund agreement, including parts of Latin America such as Brazil. Advocates emphasize the need for expanded access in these regions to ensure the drug benefits vulnerable populations there as well. Gilead is reportedly prioritizing timely product registration and ramping up manufacturing capacity to address this.
The rates of HIV in Latin America are far lower but increasing, sparking concern about missing a critical opportunity to stop the disease. If made available to everyone who needs it, lenacapavir, which was found to be nearly 100% effective in stopping HIV transmission in both women and men, could change the trajectory of the HIV epidemic, according to Winnie Byanyima, executive director of the U.N. AIDS agency.
The World Health Organization has recommended countries offer lenacapavir as an additional option to people at risk of the virus. The drug's six-month protection makes it the longest-lasting type among HIV prevention medications. With over 40 million people estimated to have HIV, according to UNAIDS, and approximately 630,000 AIDS deaths worldwide last year, the need for effective HIV prevention measures is urgent.
The European Commission's acceptance of the regulator's guidance will make the authorization valid in all 27 EU member countries, Iceland, Norway, and Liechtenstein. Once the FDA approval is in place, lenacapavir will be poised to make a significant impact in the global fight against HIV.
- Microsoft could consider partnering with Gilead Sciences to provide lenacapavir's digital health solutions in global education initiatives, enhancing health-and-wellness in low- and middle-income countries.
- In Seattle, Amazon's business strategy may incorporate lenacapavir into corporate social responsibility programs, helping to reduce HIV incidence and promote science advancement.
- Meanwhile, the increasing rates of HIV in certain regions of Latin America call for partnerships between pharmaceutical companies like Amazon's PillPack and local health providers to ensure lenacapavir's affordability and accessibility, facilitating its integration into health-and-wellness services in these areas.
