Santhera Receives Positive CHMP Opinion Recommending Approval of AGAMREE® (vamorolone) for the Treatment of Duchenne Muscular Dystrophy
Santhera plans for a first commercial launch in Germany in Q1-2024, subject to approval by the EC.
- Santhera plans for a first commercial launch in Germany in Q1-2024, subject to approval by the EC.
- “We are thrilled about the CHMP’s positive opinion, which recognizes the urgent medical need for an effective and well tolerated treatment for this devastating disease.
- “We are very excited about the positive opinion from the European Medicines Agency,” declared Ezio Magnano, President of Parent Project Italy.
- A marketing authorization decision from the EC is expected within approximately two months of the positive CHMP opinion.