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EU Regulator Backs Gilead’s Twice-Yearly HIV Prevention Shot

A final European Commission decision is expected later this year, with U.S. insurers and Medicaid programs still evaluating coverage for the injection’s $28,218 annual list price.

Gilead Sciences pharmaceutical company is seen in Oceanside, California, U.S., April 29, 2020. REUTERS/Mike Blake/File Photo
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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.