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Home Industry News Biogen reports positive clinical trial data for Spinraza

Biogen reports positive clinical trial data for Spinraza

28th April 2017

Biogen has announced the findings of a phase III clinical trial that demonstrates the safety and efficacy of its spinal muscular atrophy drug Spinraza.

Data from the CHERISH study has indicated that highly statistically significant and clinically meaningful improvements in motor function can be achieved with the use of Spinraza among children with later-onset spinal muscular atrophy, when compared to untreated children.

Children on Spinraza experienced a treatment difference of 4.9 points in the mean change from baseline to month 15 in their Hammersmith Functional Motor Scale Expanded score, a tool specifically designed to assess motor function in children with this disease.

The drug has also been evaluated in a phase II trial called NURTURE, which showed the therapy's benefits for use in infants under six weeks old with genetically diagnosed spinal muscular atrophy who were presymptomatic at treatment initiation.

Dr Alfred Sandrock, executive vice-president and chief medical officer at Biogen, said: "Our clinical development programme demonstrates the impact of early treatment, which is confirmed by NURTURE data showing significant motor milestone improvements generally consistent with normal development in presymptomatic infants treated with Spinraza."

Spinraza was recommended by the Committee for Medicinal Products for Human Use for European approval earlier this week.

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