UK's MHRA renews EAMS scientific opinion for idebenone in DMD

23 June 2020

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.

With this renewal, the MHRA again confirmed its positive scientific opinion for idebenone under the EAMS while a corresponding European marketing authorization application (MAA) is currently under review, says Switzerland-based Santhera Pharmaceuticals (SIX: SANN).

Raxone/Catena (idebenone) has not received full regulatory approval, but has also been made available under an Expanded Access Program (EAP) in the USA, as well as similar schemes elsewhere.

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