Gilead Sciences' HIV Prevention Drug Lenacapavir Receives EU Approval

Gilead Sciences' HIV prevention drug, lenacapavir, has received EU approval, increasing its stock price by 0.5%. The injectable treatment requires only twice-yearly administration, making it the first long-acting prevention option in Europe. Analysts see this as a boost to HIV prevention efforts across the region.

Gilead Sciences, Inc. (Nasdaq: GILD) announced today that the European Commission (EC) has granted marketing authorization for Yeytuo® (lenacapavir)—the company’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. This approval marks the first and only twice-yearly PrEP option to be authorized for use in the European Union’s 27 member states, as well as Norway, Iceland, and Liechtenstein [1].

The EC authorization comes after a swift review process, with the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopting a positive opinion in July 2024. The accelerated timeline reflects the significant clinical benefits of Yeytuo® compared to existing therapies [1]. The EC authorization also extends lenacapavir’s market protection in the EU by an additional year, further underscoring its potential impact on HIV prevention [1].

Yeytuo®'s approval is supported by robust clinical data from two Phase 3 trials, PURPOSE 1 and PURPOSE 2, which demonstrated its high efficacy and safety. In the PURPOSE 1 trial, twice-yearly subcutaneous lenacapavir led to zero HIV infections among participants, while the PURPOSE 2 trial showed a 99.9% reduction in HIV infections [1]. The data were published in The New England Journal of Medicine and recognized by Science as the 2024 “Breakthrough of the Year” [1].

This approval is expected to boost Gilead Sciences' stock price, as seen in the 0.5% increase following the announcement. Analysts view this as a significant advancement in HIV prevention efforts across Europe, highlighting the potential for long-acting injectable PrEP options to enhance public health outcomes [1].

Gilead Sciences is executing a global access strategy for lenacapavir, with regulatory filings ongoing in various countries. The company has also partnered with The Global Fund to supply lenacapavir for PrEP to up to two million people in low- and lower-middle-income countries, if approved [1].

In conclusion, Gilead Sciences' Yeytuo® approval by the European Commission marks a significant milestone in HIV prevention, offering a long-acting injectable option that could transform HIV prevention strategies across Europe and beyond.

References:
[1] https://www.gilead.com/news/news-details/2025/european-commission-authorizes-twice-yearly-yeytuo-lenacapavir-for-hiv-prevention