Brief: Argenx Announces FDA Acceptance Of Supplemental Biologics License Application With Priority Review For Vyvgart Hytrulo
20/02/2024 06:03
Feb 20 (Reuters) - Argenx Se ARGX.BR :
* ARGENX ANNOUNCES FDA ACCEPTANCE OF SUPPLEMENTAL BIOLOGICS
LICENSE APPLICATION WITH PRIORITY REVIEW FOR VYVGART HYTRULO IN
CHRONIC INFLAMMATORY DEMYELINATING POLYNEUROPATHY
* PRESCRIPTION DRUG USER FEE ACT (PDUFA) TARGET ACTION DATE
IS
JUNE 21, 2024
* STUDY MET ITS PRIMARY ENDPOINT (P=0.000039), DEMONSTRATING
A 61%
LOWER RISK OF RELAPSE
* ARGENX - ANNOUNCED THAT U.S. FDA HAS ACCEPTED FOR PRIORITY
REVIEW A SUPPLEMENTAL BIOLOGICS LICENSE APPLICATION (SBLA) FOR
VYVGART HYTRULO
* VYVGART HYTRULO WAS WELL-TOLERATED WITH A SAFETY PROFILE
THAT IS
CONSISTENT WITH PRIOR CLINICAL TRIALS AND KNOWN PROFILE OF
VYVGART
Source text for Eikon: ID:nGNX8ftS5w
Further company coverage: ARGX.BR
((Reuters.Briefs@thomsonreuters.com;))
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