Biogen has announced that its drug Spinraza has been recommended for European regulatory approval by the Committee for Medicinal Products for Human Use (CHMP).
The European Medicines Agency committee has adopted a positive opinion recommending marketing authorisation for Spinraza as a treatment for spinal muscular atrophy (SMA) under an accelerated assessment programme.
“Biogen's Spinraza has been recommended for European regulatory approval as a treatment for spinal muscular atrophy.“
This regulatory mechanism is designed to facilitate earlier access to patients for medicines that fulfil unmet medical needs, with Biogen's drug being the first treatment for SMA to be recommended by the CHMP for approval in the European Union.
Data from two pivotal controlled studies, ENDEAR and CHERISH, both demonstrated the clinically meaningful efficacy and favourable safety profile of this new drug.
Dr Michael Ehlers, executive vice-president for research and development at Biogen, said: "The positive CHMP opinion, which was expedited under the accelerated assessment programme, recognises the compelling efficacy profile of Spinraza and underscores the significant unmet need for an effective SMA treatment in Europe."
Biogen has licensed the global rights to develop, manufacture and commercialise Spinraza from Ionis Pharmaceuticals, with developed the drug alongside Biogen.
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