By Colin Kellaher
Gilead Sciences said a key European regulatory committee recommended accelerated approval of its twice-yearly lenacapavir injection for HIV prevention.
Gilead on Friday said the recommendation by the European Medicines Agency's Committee for Medicinal Products for Human Use covers lenacapavir for use as pre-exposure prophylaxis, or PrEP, to reduce the risk of sexually acquired HIV-1 in adults and adolescents with increased HIV-1 acquisition risk.
The European Commission, which generally follows CHMP's advice, will now review the recommendation, with a decision expected later this year.
Gilead said a green light would make lenacapavir the first and only twice-yearly HIV PrEP option in the European Union.
The Foster City, Calif., biopharmaceutical company said it plans to market lenacapavir under the trade name Yeytuo in the EU.
The U.S. Food and Drug Administration last month approved the lenacapavir, marketed in the U.S. as Yeztugo, making it the longest-acting PrEP drug on the market.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
July 25, 2025 06:24 ET (10:24 GMT)
Copyright (c) 2025 Dow Jones & Company, Inc.