Ceratium are delighted to announce that the VISION DMD pivotal clinical study has been instrumental in paving the way for recommendations to approve of the new steroid-like drug vamorolone to treat Duchenne Muscular Dystrophy (DMD) patients.
The Ceratium team have been involved from writing the €6M Horizon 2020 grant to managing the EC grant funded parts of the VISION-DMD project. The proposal scored 15/15 and has included multiple innovations in a multi-actor collaboration led by ReveraGen and The University of Newcastle John Walton Centre.
Santhera Pharmaceuticals has an exclusive license for vamorolone from ReveraGen for all indications. They report the Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for AGAMREE® (vamorolone) for the treatment Duchenne muscular dystrophy (DMD) in children and adults aged 4 years and older. The EC decision on marketing authorization is expected in late 2023. This could make AGAMREE could become the first drug fully approved by the European Medicines Agency (EMA) for the treatment of patients with DMD. Approval in the US is also expected soon. The full Santera press release is available here. This is great news for the DMD Patient Community who we have had the pleasure of working with during the project.