Another Setback For Santhera’s Idebenone DMD Hopes

EU Opinion On Marketing Suitability Is Delayed To Year-End

 
• By Maureen Kenny
  
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Santhera needs more time to address concerns regarding its current EU application for idebenone in the DMD setting but the Swiss biotech is keeping its sights on a broader indication.

Link between genetics and various dystrophy disorders
DMD is a genetic disorder characterized by progressive muscle degeneration and weakness • Source: Shutterstock

Santhera Pharmaceuticals AG has been given more time to answer questions from the European Medicines Agency’s drug evaluation committee, the CHMP, about the company’s EU marketing approval application (MAA) for idebenone. This is the product the Swiss company has been trying for years to get to show enough promise in Duchenne muscular dystrophy (DMD) to secure regulatory approval.

Santhera says this will delay to the final quarter of 2020 the decision on whether idebenone should be approved in...

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