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.

 

Innovation & Research Strategy

Innovation & Research Strategy

We bring independent thinking and insight to help clients develop and refine excellent research proposals and business plans...

FIND OUT MORE

Funding

Funding

We have been successful in multiple EU and UK funding applications and can provide help and advice about the suitability of your research plans for National and European...

FIND OUT MORE

Project Management

Project Management

Successful projects require a focused approach to project management. Our experienced professionals can provide management support to...

FIND OUT MORE

Communication

Communication

Scientific advances influence almost all parts of society, so scientists and the research community have a duty to communicate research results...

FIND OUT MORE

Exploitation & Impact

Exploitation & Impact

Demonstrating the impact of research is now critical to modern projects and forms a key criterion of proposal evaluation...

FIND OUT MORE

Training

Training

Our aim is to help you understand grant funding, learn the key elements of a winning proposal and how to manage a collaborative project...

FIND OUT MORE