Biogen announces FDA approval of high dose regimen of Spinraza

Biogen (BIIB) announced that the high dose regimen of Spinraza, which is comprised of 50 mg/5 mL and 28 mg/5 mL doses, was approved by the FDA for the treatment of spinal muscular atrophy. Backed by more than 10 years of clinical data supporting the low dose regimen of Spinraza, 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, which will be available in the coming weeks, 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. Patients transitioning from the low dose regimen would follow their existing dosing schedule at four-month intervals after a single High Dose loading phase.