Brief: Reg-Orphazyme Provides Regulatory Update Following Type A Meeting With FDA On Arimoclomol In Niemann-Pick Disease Type C

Strategic Partners A/S

31/10/2021 20:03

Oct 31 (Reuters) - Orphazyme A/S  ORPHA.CO :
    * REG-ORPHAZYME PROVIDES REGULATORY UPDATE FOLLOWING TYPE A
MEETING WITH FDA ON ARIMOCLOMOL IN NIEMANN-PICK DISEASE TYPE C
    * FDA RECOMMENDS THE COMPANY PROVIDES SUPPLEMENTAL
INFORMATION AND
ANALYSES
    * FDA OFFERS TO HAVE FURTHER INTERACTIONS TO IDENTIFYA PATH
TO
RESUBMISSION FOR ARIMOCLOMOL IN NPC
    * FDA AFFIRMED THAT IT WOULD REQUIRE ADDITIONAL IN VIVO OR
PHARMACODYNAMIC (PD)/PHARMACOKINETIC (PK) DATA
    * FDA CONCURRED WITH COMPANY'S PROPOSAL TO REMOVE COGNITION
DOMAIN
FROM NPCCSS ENDPOINT

Source text for Eikon:  ID:nGNE8r78vf 
Further company coverage:  ORPHA.CO 

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