Gilead Sciences Receives Positive CHMP Opinion for Twice-Yearly HIV PrEP Lenacapavir, Awaits Final EU Decision

Reuters
07-25
<a href="https://laohu8.com/S/GILD">Gilead</a> Sciences Receives Positive CHMP Opinion for Twice-Yearly HIV PrEP Lenacapavir, Awaits Final EU Decision

Gilead Sciences Inc. has announced that the European Medicines Agency's Committee for Medicinal Products for Human Use $(CHMP)$ has adopted a positive opinion under accelerated review for lenacapavir, recommending its use as pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in adults and adolescents at increased risk. If approved by the European Commission later this year, lenacapavir will be marketed in the EU under the trade name Yeytuo®. This development represents a significant step towards introducing a twice-yearly HIV prevention option in Europe. Additionally, a positive opinion was received for the EMA's EU-M4all procedure, which aims to facilitate the drug's availability in low- and lower-middle-income countries. This initiative is part of Gilead's broader global access strategy, designed to expedite regulatory review and expand access to lenacapavir for those most in need.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Gilead Sciences Inc. published the original content used to generate this news brief via Business Wire (Ref. ID: 20250724024903) on July 25, 2025, and is solely responsible for the information contained therein.

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