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‘Surprised and Disappointed’ Santhera To Fight EU’s DMD Rejection

 
• By Neena Brizmohun and Maureen Kenny

Santhera has vowed to appeal against this week’s recommendation by the European Medicines Agency that the company’s application to extend Raxone’s indication to cover DMD be rejected. The agency recommended EU approval for four other drug applications seeking extended indications.

Businessman looking through a magnifying glass to documents
Santhera wants a re-examination of the EMA's decision on Raxone for Duchenne

Santhera Pharmaceuticals is “surprised and disappointed” that EU regulators have said that its drug, Raxone (idebenone), should not be approved in the EU for the additional indication of Duchenne muscular dystrophy (DMD). The company’s share price fell sharply on the news.

Santhera is planning to appeal the negative opinion from the European Medicines Agency’s key scientific committee, the CHMP

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