Gilead Granted Marketing Authorization for Twice-Yearly HIV PrEP Shot in Europe

The European Commission (EC) has granted marketing authorization for Yeytuo (lenacapavir)—Gilead Sciences Inc.’s twice-yearly injectable HIV-1 capsid inhibitor—for use as pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in adults and adolescents with increased HIV-1 acquisition risk who weigh at least 35kg.

The marketing authorization application (MAA) was reviewed under an accelerated timeline based on the assessment by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) that twice-yearly Yeytuo is a product of major interest for public health. In July, the CHMP adopted a positive opinion recommending Yeytuo for EC authorization. Additionally, lenacapavir will be granted one additional year of market protection in the EU as a result of the new indication, following a scientific evaluation prior to authorization that demonstrates it brings significant clinical benefit compared to existing therapies.

“Yeytuo’s rapid authorization by the European Commission underscores the rigor of our clinical data and the transformative potential of Yeytuo to help address the urgent unmet need in HIV prevention across Europe,” said Dietmar Berger, MD, PhD, Chief Medical Officer at Gilead Sciences. “This milestone is a testament to the 17 years of Gilead research that delivered this breakthrough PrEP medication, underpinned by decades of leadership in HIV innovation.”

The EC authorization follows approval by the U.S. Food and Drug Administration (FDA) in June, as well as the issuance of guidelines by the World Health Organization (WHO) in July that recommended twice-yearly lenacapavir as an additional PrEP option for HIV prevention.