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Biogen’s Spinraza Needs Long-Term Confirmatory Data, Says EMA

 
• By John Davis

The EMA may have quickly assessed the US biotech’s antisense spinal muscular atrophy therapy for Europe, but the product’s rapid clinical development means long-term data, and data on its effects in milder disease, or even cures, still need to be collected.

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Although the clinical development of Biogen’s antisense product Spinraza (nusinersen) for spinal muscular atrophy (SMA) in around five years is a remarkable achievement, it does mean the long-term effects of the product are relatively unknown.

In recommending approval of the drug on April 21 following review by the Committee on Medicinal Products for Human Use...

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