Gilead Reports the EMA’s MAA and EU-M4all Acceptance of Lenacapavir for Pre-Exposure Prophylaxis (PreP) to Prevent HIV in Individuals at Risk

Shots:The EMA has accepted MAA & EU-M4all as well as granted priority review to lenacapavir (HIV-1 capsid inhibitor) for PrEP in humans at risk of HIV; MAA will be applicable in 30 EEA states (incl. Norway, Iceland & Liechtenstein) MAA was based on P-III (PURPOSE 1 & PURPOSE 2) trials assessing lenacapavir (SC;…

ByRidhi RastogiFebruary 25, 2025

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Gilead Reports US FDA’s NDA Acceptance of Lenacapavir for Pre-Exposure Prophylaxis (PreP) to Prevent HIV in Individuals at Risk

Shots:The US FDA has accepted & granted priority review to the NDA of lenacapavir (HIV-1 capsid inhibitor) for PreP in individuals at risk of HIV (PDUFA: Jun 19, 2025); MAA & EU-M4all application has been filed to the EMA NDA was based on P-III (PURPOSE 1 & PURPOSE 2) trials assessing lenacapavir (SC; twice…

ByRidhi RastogiFebruary 19, 2025

Gilead Reports the EMA’s MAA and EU-M4all Acceptance of Lenacapavir for Pre-Exposure Prophylaxis (PreP) to Prevent HIV in Individuals at Risk

Gilead Reports US FDA’s NDA Acceptance of Lenacapavir for Pre-Exposure Prophylaxis (PreP) to Prevent HIV in Individuals at Risk

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Gilead Reports the EMA’s MAA and EU-M4all Acceptance of Lenacapavir for Pre-Exposure Prophylaxis (PreP) to Prevent HIV in Individuals at Risk

Gilead Reports US FDA’s NDA Acceptance of Lenacapavir for Pre-Exposure Prophylaxis (PreP) to Prevent HIV in Individuals at Risk

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