Posted by Michael Wonder on 23 Jun 2020
MHRA extends access to Santhera's DMD drug via the EAMS
23 June 2020 - The UK’s Medicines and Healthcare products Regulatory Agency has renewed for a further year the Early Access to Medicines Scheme scientific opinion for Santhera's Duchenne muscular dystrophy drug idebenone.
The drug is being developed for patients with Duchenne muscular dystrophy in respiratory function decline who are not taking glucocorticoids.
With this renewal, the Medicines and Healthcare products Regulatory Agency has confirmed its positive scientific opinion for idebenone under the Early Access to Medicines Scheme while a corresponding European marketing authorisation application is currently under review.
