Santhera can carry on making Raxone available to patients with Duchenne muscular dystrophy in the UK under the early access to medicines scheme while the MHRA works out what to do now that the European Medicines Agency has turned the product down. In the US, meanwhile, the company has received the green light to provide the drug to DMD patients at no cost under a similar scheme.
The UK’s early access to medicines scheme (EAMS) has entered uncharted territory, following the European Medicines Agency’s rejection of Santhera’s bid to extend the indication of its drug Raxone to the treatment of Duchenne muscular dystrophy.
The EMA’s decision on Jan