WESTON (dpa-AFX) - Biogen Inc. (BIIB) announced Monday that the High Dose Regimen of SPINRAZA (nusinersen), which is comprised of 50 mg/5 mL and 28 mg/5 mL doses, was approved by the U.S. Food and Drug Administration (FDA) for the treatment of spinal muscular atrophy (SMA).
Backed by more than 10 years of clinical data supporting the Low Dose Regimen of SPINRAZA (12 mg), High Dose SPINRAZA was designed to deliver a higher concentration of drug through both the loading and maintenance dosing phases, to provide a new option in response to the ongoing needs of the community.
The High Dose Regimen of SPINRAZA enables an accelerated loading phase for those new to SPINRAZA treatment - with two 50 mg doses administered 14 days apart - followed by 28 mg maintenance dose injections every four months thereafter.
The FDA approval is based on data from the three-part, Phase 2/3 DEVOTE study. Results from the pivotal cohort of the study showed treatment-naïve, symptomatic infants who received High Dose SPINRAZA experienced statistically significant improvements in motor function as measured by the Children's Hospital of Philadelphia Infant Test of Neuromuscular Disorders (CHOP-INTEND), when compared to a prespecified matched sham (untreated) group from the ENDEAR study.
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.
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