The US Food and Drug Administration (FDA) and European Medicines Agency (EMA) have accepted Biogen’s applications for a higher dose regimen of spinal muscular atrophy (SMA) treatment Spinraza ...

Over the past nine years, patients with spinal muscular atrophy have seen the number of FDA-approved treatment options for ...

Applications are based on data from the DEVOTE study, which demonstrate the potential for the investigational higher dose regimen of nusinersen to advance the treatment of SMACAMBRIDGE, Mass., Jan. 23 ...

Biogen has announced that the European Medicines Agency (EMA) and US Food and Drug Administration (FDA) have started reviewing a higher dose regimen of its spinal muscular atrophy (SMA) treatment ...

This new regimen includes a faster loading schedule and increased maintenance dose compared to the currently approved dosing of SPINRAZA. Biogen's officials expressed optimism about the potential ...

Nusinersen is currently commercialized under the brand name SPINRAZA in over 71 countries at the label-approved dose of 12 mg. About the DEVOTE StudyDEVOTE was a Phase 2/3 randomized, controlled ...

Biogen said U.S. and European regulators will review its applications seeking approval of a higher-dose regimen of its Spinraza drug for the neuromuscular disease spinal muscular atrophy.

Biogen’s applications for the higher dose regimen of SMA drug Spinraza are now under review in the US and Europe.