FDA and EMA Accept Applications for Higher Dose Regimen of Nusinersen in SMA

US/EU regulators start review of Biogen's high-dose Spinraza

Biogen's new high-dose version of SMA drug Spinraza has started regulatory reviews, but can it help return the drug to growth?

FDA and EMA Accept Applications for Higher Dose Regimen of Nusinersen in SMA

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 SMA

FDA accepts sNDA for higher regimen nusinersen for spinal muscular atrophy

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 4 months.

US, EU regulators to review higher-dose Spinraza for use in SMA

Regulators in the U.S. and the European Union have agreed to review Biogen’s applications seeking approval of a higher dose of Spinraza (nusinersen) for all types of spinal muscular atrophy (SMA) in individuals of all ages — a regimen the therapy’s developer says may provide more effective treatment for patients. According to Biogen, the U.S. Food and Drug Administration accepted its supplemental new drug application for the new dosing regimen. …

FDA and EMA Accepts Applications for New Nusinersen Regimen

An investigational higher dose of spinal muscular atrophy drug nusinersen gains attention as the FDA and European Medicines Agency (EMA) considerate it as an alternative than the current lower FDA-approved dosage.

FDA Accepts sNDA for Higher Dosing Regimen of Nusinersen for Spinal Muscular Atrophy

In the phase 2/3 DEVOTE study, a higher dose of nusinersen met its primary end point at 6 months, achieving a statistically significant improvement in motor function among treatment-naïve symptomatic infants with SMA.