UK's MHRA renews EAMS status for idebenone in DMD

24 June 2019

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has renewed for a further year the Early Access to Medicines Scheme (EAMS) scientific opinion for idebenone for patients with Duchenne muscular dystrophy (DMD) in respiratory function decline who are not taking glucocorticoids, Switzerland-based Santhera Pharmaceuticals (SIX: SANN) announced today.

With this renewal, the MHRA again confirmed its positive scientific opinion for idebenone under the EAMS while a corresponding European marketing authorization application (MAA) has recently been submitted.

Santhera’s shares were up 2.5% at 14.70 Swiss francs in early-afternoon trading.

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