drugset / Press release

SPINRAZA® (nusinersen) Approved in the European Union

2017-06-01 · Ionis Pharmaceuticals · original ionis.com ↗

First Approved Treatment in EU for SMA Approved to Treat Broad Range of People with SMA Ionis Earns $50 Million Milestone CARLSBAD, Calif., June 1, 2017 /PRNewswire/ -- Ionis Pharmaceuticals, Inc. (NASDAQ: IONS) announced today that the European Commission (EC) has granted marketing authorization for SPINRAZA® (nusinersen) for the treatment of 5q spinal muscular atrophy (SMA). 5q SMA is the most common form of the disease and represents approximately 95% of all SMA cases. SPINRAZA is the first approved treatment in the European Union (EU) for SMA, a leading genetic cause of death in infants that is marked by progressive, debilitating muscle weakness. SPINRAZA was reviewed under the European Medicines Agency's (EMA) accelerated assessment program, intended to expedite access to patients with unmet medical needs.

The release as fetched from its publisher. ionis.com ↗