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UK patients gain early access to Duchenne drug
UK patients can gain access to Santhera’s as-yet unapproved Duchenne muscular dystrophy drug via an early access scheme.
The Medicines and Healthcare products Regulatory Agency granted Raxone (idebenone) a positive scientific opinion through the Early Access to Medicines Scheme (EAMS).
As a result of the decision, patients aged 10 and above with respiratory function decline, who are not taking gluticorticoids, will be able to get access to Raxone ahead of formal approval by the European Medicines Agency.
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Santhera Submits Marketing Authorization Application to the European Medicines Agency for Puldysa® (Idebenone) in D...Santhera Pharmaceuticals announces that ...
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Santhera’s Raxone® receives first positive EAMS scientific opinion from UK’s MHRA in Duchenne muscular ...The aim of the EAMS is to provide patien...
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Phase III Study With Idebenone in Patients With Duchenne Muscular Dystrophy (SIDEROS-E)The purpose of the study is to assess th...
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Idebenone reduces respiratory complications in patients with Duchenne muscular dystrophyIn Duchenne muscular dystrophy (DMD), pr...
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A Phase III Double-blind Study With Idebenone in Patients With Duchenne Muscular Dystrophy (DMD) Taking Glucocortico...The purpose of the study is to assess th...
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Expanded Access Program for Idebenone in Participants With Duchenne Muscular Dystrophy (DMD)The primary objective of this Expanded A...
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Santhera Provides Update on Filing for Conditional Marketing Authorization in Europe for Puldysa® (Idebenone) in Du...Santhera Pharmaceuticals announces its i...
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Santhera to Present Long-term Efficacy Results with Idebenone in DMD at the 2019 MDA Clinical and Scientific Confere...Santhera Pharmaceuticals and its collabo...
