Gilead Sciences Receives Favorable CHMP Opinion for HIV Prevention Drug Lenacapavir

Gilead Sciences has received a favorable opinion from the European Medicines Agency's CHMP for lenacapavir, a twice-yearly injectable HIV PrEP alternative. If approved, it would be the first of its kind in the EU. Lenacapavir has been endorsed for low- and lower-middle-income nations and has shown 100% HIV prevention in Phase 3 data from the PURPOSE 1 and 2 studies. The final EC ruling is expected later this year.

Gilead Sciences, Inc. has received a favorable opinion from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) for lenacapavir, a twice-yearly injectable HIV pre-exposure prophylaxis (PrEP) alternative [1]. This approval marks a significant milestone for the company and the HIV prevention landscape in the European Union.

Lenacapavir, which demonstrated zero HIV infections in its Phase 3 PURPOSE 1 trial and a 99.9% efficacy rate in the PURPOSE 2 trial, is set to be the first of its kind in the EU if approved [1]. The drug is being evaluated under an accelerated review timeline due to its potential public health interest and therapeutic innovation [1]. The EMA's validation follows the U.S. Food and Drug Administration's (FDA) acceptance of Gilead’s New Drug Applications (NDAs) for lenacapavir under priority review [1].

The EMA's decision paves the way for lenacapavir's availability in all 27 EU Member States, as well as Norway, Iceland, and Liechtenstein, through the centralized licensing procedure [1]. Additionally, the EU-Medicines for all (EU-M4all) application seeks a CHMP opinion to facilitate more expedited review processes in low- and lower-middle-income countries, potentially accelerating access to lenacapavir for PrEP [1].

The final EC ruling on lenacapavir is expected later this year. If approved, the drug will be a significant advancement in HIV prevention, offering an alternative to daily oral pills and addressing issues of adherence and stigma [2]. Gilead aims for 90% U.S. insurer coverage within a year and global expansion via partnerships, including the provision of 2 million free doses for low-income countries [2].

The HIV drugs market is projected to grow to $44.5 billion by 2030, and Gilead's portfolio currently generates $28.3 billion in revenue, with raised 2025 expectations [2]. Lenacapavir's success in clinical trials and regulatory approvals underscores Gilead's strategic momentum and commitment to addressing the HIV epidemic globally.

References:

[1] https://www.gilead.com/news/news-details/2025/european-medicines-agency-validates-gileads-marketing-authorization-application-and-eu-medicines-for-all-application-for-twice-yearly-lenacapavir-for-hiv-prevention

[2] https://www.ainvest.com/news/gilead-sciences-strategic-momentum-yeztugo-hiv-portfolio-growth-cornerstone-long-term-creation-2508/