European nod for Spinraza

US biotech Biogen’s (Nasdaq: BIIB) Spinraza (nusinersen) has been approved in the European Union (EU) for the treatment of 5q spinal muscular atrophy (SMA).

It is the first approved treatment in the EU for SMA, a leading genetic cause of death in infants that is marked by progressive, debilitating muscle weakness, and the 5q form is the disease’s most common, representing 95% of cases of SMA.

Spinraza, which was approved by the US Food and Drug Administration in December 2016, was reviewed under the European Medicines Agency’s accelerated assessment program, intended to expedite access to patients with unmet medical needs.