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EMA Rejection For Raxone Plunges UK Early Access Scheme Into Uncharted Territory

Executive Summary

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.

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