Spinraza Recommended for Approval in Europe
The new spinal muscular atrophy (SMA) treatment Spinraza has been recommended for European approval by the Committee for Medicinal Products for Human Use (CHMP), which is part of the European Medical Association (EMA).
Biogen, the makers of the drug, made the announcement in a press release. The news means that children and adults with all types of SMA in Europe may soon be able to start treatment on Spinraza (also known as nusinersen). If approved by the EMA, it will be the first treatment available for people with the disease in Europe, following the U.S. approval of the drug in December.
The positive opinion of Spinraza has now been referred to the European Commission (EC) and a decision regarding the approval should happen over the coming months. Find out more about the positive opinion of Spinraza in Europe here.
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