Santhera Pharmaceuticals Holding AG (SPHDF)
- GlobeNewswire
Santhera Announces NDA for Vamorolone in Duchenne Muscular Dystrophy Accepted and Granted Priority Review by China’s NMPA
Pratteln, Switzerland, March 27, 2024 – Santhera Pharmaceuticals (SIX: SANN) announces that the China National Medical Products Administration (NMPA) has accepted for priority review the new drug application (NDA) for vamorolone in Duchenne muscular dystrophy (DMD) which was submitted by Sperogenix Therapeutics, Santhera's specialized rare disease partner for China. The Center for Drug Evaluation (CDE) of the Chinese drug authority NMPA accepted the filing and granted priority review for vamorol
- GlobeNewswire
Santhera’s Partner Catalyst Pharmaceuticals Launches AGAMREE® (Vamorolone) in the United States
AGAMREE® is U.S. FDA approved and now available in the United States for the treatment of Duchenne muscular dystrophy (DMD) in patients 2 years of age and olderThis follows the first commercial launch of AGAMREE in Germany in January 2024 by SantheraAGAMREE is the first DMD treatment approved across the U.S., EU and UK Pratteln, Switzerland, March 14, 2024 – Santhera Pharmaceuticals (SIX: SANN) is pleased to note the launch of AGAMREE® (vamorolone) for the treatment of Duchenne muscular dystroph
- GlobeNewswire
Santhera Announces Publication of Efficacy, Safety and Tolerability Data with Vamorolone (AGAMREE®) in Patients with Duchenne Muscular Dystrophy in Neurology
Results from 112 patients with DMD who completed the study confirm maintenance of efficacy and benefits in safety and tolerability of treatment with vamorolone over 48 weeks AGAMREE® has shown safety benefits in patients switching from standard of care corticosteroids in terms of recovery of bone health and growth More than 200 patients have now been treated with vamorolone for up to 84 months across clinical studies and access programs AGAMREE® is the only approved medication in the European Un
