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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 (CHMP), the European Medicines Agency notes that because patients treated...

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