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吉利德周刊Yeztugo HIV药丸sNDA被FDA接受

2026-06-16 05:14

  • The US FDA has accepted for review an application from Gilead Sciences (GILD) for a once-weekly pill version of Yeztugo (lenacapavir) for pre-exposure prophylaxis (PrEP) of HIV.
  • The sNDA has an FDA action date of Feb. 2, 2027.
  • The application is supported by data from the PURPOSE 1 and PURPOSE 2 trials.
  • Yeztugo is currently approved as an injection. After initiation dosing, subsequent doses are given every six months.

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