drugset / Press release

FDA Approves New High Dose Regimen of SPINRAZA® (nusinersen) for Spinal Muscular Atrophy

2026-03-30 · Biogen · original biogen.com ↗

The approval was anchored on data from the pivotal DEVOTE study that investigated the efficacy and safety of the High Dose Regimen of SPINRAZA in treatment-naïve and previously treated SPINRAZA patients High Dose SPINRAZA will be available in the United States in the coming weeks and is also approved in the European Union, Switzerland and Japan

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