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EMA updates Spinraza's product summary, gives Biogen hope in Denmark

The EMA has added real-world clinical findings for adult patients to the summary for Biogen’s spinal muscular atrophy (SMA) treatment, Spinraza. The company’s Danish division now hopes this will pave the way to expand the drug’s indication in Demark, whose health authority has proved a roadblock many times.

Tashia Lentz, managing director at Biogen Denmark | Photo: Biogen Danmark / PR

The European Medicines Agency (EMA) has recently updated the product summary for Biogen’s spinal muscular atrophy (SMA) treatment, Spinraza (nusinersen), which now includes real-world clinical data that demonstrates the drug’s effectiveness in stabilizing or improving the motor function of some adults with SMA.

Spinraza was approved in the EU around five years ago, but the drug has been heavily debated in Denmark. As a consequence, the Danish Medicines Agency has only been prepared to recommend use for a limited patient population – infants and children under age 6 with type I and type II SMA.

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