Brief: Santhera Receives Positive CHMP Opinion Recommending Approval Of Agamree® (Vamorolone) For The Treatment Of Duchenne Muscular Dystrophy

Santhera Pharmaceuticals Holding AG

13/10/2023 06:03

Oct 13 (Reuters) - Santhera Pharmaceuticals Holding AG
 SANN.S :
    * SANTHERA RECEIVES POSITIVE CHMP OPINION RECOMMENDING
APPROVAL OF
AGAMREE® (VAMOROLONE) FOR THE TREATMENT OF DUCHENNE MUSCULAR
DYSTROPHY
    * PLANS FOR A FIRST COMMERCIAL LAUNCH IN GERMANY IN Q1-2024,
SUBJECT TO APPROVAL BY EC
    * ANTICIPATION OF VAMOROLONE APPROVAL IN U.S. ON PDUFA DATE
OF
OCTOBER 26, 2023
    * EUROPEAN COMMISSION (EC) DECISION ON MARKETING
AUTHORIZATION IS
EXPECTED IN LATE 2023

Source text for Eikon:  ID:nGNX1frrRD 
Further company coverage:  SANN.S 

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