Overview

• The European Medicines Agency’s human medicines committee recommended authorizing lenacapavir on July 25, positioning it as the first six-month HIV prevention option in Europe pending formal Commission sign-off.
• Lenacapavir received U.S. Food and Drug Administration approval on June 18 and earned a World Health Organization endorsement in early July for twice-yearly pre-exposure prophylaxis.
• Phase 3 trials demonstrated nearly 100% effectiveness at preventing HIV transmission and showed an 89% adherence advantage over daily oral PrEP due to the biannual injection schedule.
• Yeztugo carries a $28,218 annual list price in the U.S., with Medicare agreeing to cover it but state Medicaid reviews and private insurer decisions still underway.
• If the European Commission approves lenacapavir later this year, it will gain an additional year of market exclusivity in the EU under the brand name Yeytuo, delaying generic competition.