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Santhera's AGAMREE® (Vamorolone) Approved in the European Union for the Treatment of Duchenne Muscular Dystrophy

European Commission (EC) grants marketing authorization for AGAMREE® for the treatment of Duchenne muscular dystrophy (DMD) in patients aged 4 years and olderAGAMREE® is the only approved medication in the European Union (EU) for treating DMD, and the first DMD treatment approved in both the U.S. and EUFirst commercial launch of AGAMREE®, in Germany, expected in Q1-2024 EMA acknowledges safety benefits of AGAMREE® with regards to preserving bone health and maintaining growth compared to standard ....

United Kingdom , Switzerland General , United States , Elizabeth Vroom , Dario Eklund , Eva Kalias , Energyx Ray Absorptiometry , Committee For Medicinal Products Human Use , European Union , Santhera Pharmaceuticals , World Duchenne Organization , Head Investor Relations Communications , Drug Administration , European Medicines Agency , Catalyst Pharmaceuticals , Life Science Alliance , Santhera Pharmaceuticals Holding , America To Catalyst Pharmaceuticals , Regulatory Agency , European Commission , Duchenne Organization , World Duchenne , Dual Energyx Ray Absorptiometry , Medicinal Products , Human Use , North America ,

Santhera Receives U.S. FDA Approval of AGAMREE® (vamorolone) for the Treatment of Duchenne Muscular Dystrophy

Ad hoc announcement pursuant to Art. 53 LR Food and Drug Administration (FDA) approved AGAMREE® (vamorolone) for the treatment of Duchenne muscular dystrophy (DMD) in children and adults aged 2 years and olderU.S. license holder Catalyst Pharmaceuticals plans for commercial launch in Q1-2024FDA approval triggers USD 36 million payment obligation from Catalyst to Santhera, of which USD 26 million will be used to cover Santhera’s third-party milestone obligationsFollowing the recent positive CHMP ....

Switzerland General , United Kingdom , United States , Reveragen Biopharma , Eva Kalias , Eric Hoffman , Dario Eklund , European Union , Santhera Pharmaceuticals , Santhera Pharmaceuticals Holding , America To Catalyst Pharmaceuticals , Head Investor Relations Communications , European Commission , Regulatory Agency , Drug Administration , Life Science Alliance , Catalyst Pharmaceuticals , European Medicines Agency , European Medicines , Pat Furlong , Founding President , Project Muscular Dystrophy , North America , Orphan Drug , Fast Track , Rare Pediatric Disease ,