Biotechnology company Biogen Inc (Nasdaq:BIIB) announced on Thursday that the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have accepted applications for a higher dose regimen of nusinersen for spinal muscular atrophy (SMA).

The applications are based on data from the DEVOTE study, which demonstrated the potential for the higher dose regimen to advance the treatment of SMA. The higher dose regimen of nusinersen comprises a more rapid loading regimen, two 50 mg doses 14 days apart, and higher maintenance regimen, 28 mg, every four months, compared to the currently approved regimen.

Nusinersen, marketed as SPINRAZA, is approved in over 71 countries to treat individuals with SMA. The current 12 mg regimen of SPINRAZA is administered in four loading doses over approximately 60 days, followed by maintenance dosing every four months.

SPINRAZA is an antisense oligonucleotide that increases the production of full-length survival motor neuron (SMN) protein in the body. Biogen licensed the global rights to SPINRAZA from Ionis Pharmaceuticals Inc (Nasdaq:IONS).