+ Regulatory
Nicholas Gueguen | Jun 11, 2017

European Commission OKs Spinraza to fight spinal muscular atrophy

The European Commission has allowed Spinraza to be used to combat 5q spinal muscular atrophy.

The European Commission decided to allow Spinraza to be used to fight the condition based on studies results of the condition in babies and people who developed the condition after infancy, according to a Biogen press release.

The results of the infant study showed that 51 percent of those who took Spinraza reached "motor milestones," while those who didn't take Spinraza failed reached "motor milestones," the release said. The study also showed that babies who took Spinraza were 47 percent less likely to die or have to use a ventilator for the rest of their lives.

Biogen also released information from the study of people who developed spinal muscular atrophy beyond infancy. In that study, children who took Spinraza saw their motor skills get better at a much higher rate than those who didn't take Spinraza, and their motor skills getting better was in ways important to clinicians.

According to the release, the Food and Drug Administration approved Spinraza on Dec. 23.

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+ Biogen

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