EC gives green light to new HIV prevention therapy

The European Commission has issued a marketing authorization for the first injectable HIV-1 capsid inhibitor – lenacapavir. It will be administered only twice a year, once every six months, announced the manufacturer Gilead. The drug will be marketed under the brand name Yeytuo. It is intended for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in adults and adolescents at increased risk. A condition for application is a body weight of over 35 kg.

Yeytuo is the first and only PrEP therapy with a six-month dosing regimen. It has already received approval for use in all 27 EU member states. In addition to these, approval for use has also been granted for the countries of the European Economic Area – Norway, Iceland, and Liechtenstein.

The application was reviewed under an accelerated procedure by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). The reason is that the medication is of great public health importance. In July, the CHMP issued a positive opinion and recommendation for EC approval. Furthermore, the drug receives an additional year of market protection in the EU, thanks to its proven clinical benefit compared to existing therapies.

The EC approval follows the authorization by the U.S. Food and Drug Administration (FDA) in June, as well as the guidelines issued by the WHO. These recommend the administration of the medication twice a year as an additional PrEP option for HIV prevention.

“With nearly 25,000 new HIV cases annually in the EU and the European Economic Area,

it is evident that existing preventive options are insufficient,” commented Dr. Jean-Michel Molina. He is a professor of infectious diseases at Université Paris Cité and head of the infectious diseases department at Saint-Louis and Lariboisière hospitals. “The new dosing regimen of Yeytuo and its high efficacy could become a long-awaited transformative option for HIV prevention in Europe. It will help us reduce new infections and make progress in the fight against the epidemic,” Dr. Molina added.

As a reminder, in December 2024, Science magazine named lenacapavir the “Breakthrough of the Year.”