Brief: U.S. FDA Defers Action On Filing For At-Gaa In Late-Onset Pompe Disease

Amicus Therapeutics

28/10/2022 21:26

Oct 28 (Reuters) - Amicus Therapeutics Inc  FOLD.O :
    * U.S. FDA DEFERS ACTION ON FILING FOR AT-GAA IN LATE-ONSET
POMPE
DISEASE
    * AMICUS THERAPEUTICS INC - COMPANY IS NOW ACTIVELY ENGAGED
WITH
AGENCY TO DEVELOP PLANS AND LOGISTICS FOR A PRE-APPROVAL
INSPECTION
    * AMICUS THERAPEUTICS- CONTINUES TO EXPECT FDA TO APPROVE
TWO
COMPONENTS OF AT-GAA, INCLUDING BLA AND NEW DRUG APPLICATION FOR
MIGLUSTAT, TOGETHER
    * AMICUS - FDA ISSUES DEFERRED ACTION LETTER ON AT-GAA
FILING DUE
TO INABILITY TO CONDUCT REQUIRED MANUFACTURING SITE INSPECTION
PRIOR TO PDUFA DATE

Source text for Eikon:  ID:nGNX6pFtwV 
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