Biogen has announced that its drug Spinraza has been approved by the European Commission for the treatment of spinal muscular atrophy.
The drug has been ratified as a first treatment for 5q spinal muscular atrophy, the most common form of the disease, which accounts for approximately 95 percent of all cases. It was reviewed under an accelerated assessment programme to expedite access to patients with unmet medical needs.
“Biogen's Spinraza has been approved in Europe for use as an initial treatment for spinal muscular atrophy.“
This approval was based on results from two pivotal studies, including end-of-study data from the ENDEAR trial and an interim analysis of the CHERISH study, both of which demonstrated the clinically meaningful efficacy and favourable benefit-risk profile of Spinraza.
The approval was also supported by open-label data in presymptomatic and symptomatic individuals with or likely to develop the type 1, 2 and 3 variants of the disease.
Michel Vounatsos, chief executive officer at Biogen, said: "Based on the robust efficacy and safety profile demonstrated in the clinical trials, we believe Spinraza will have a meaningful impact on infants, children and adults living with this devastating disease."
Spinraza was approved in the US last December, with regulatory filings in Japan, Canada, Australia, Switzerland and Brazil also pending.
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