Biogen获得FDA批准大剂量Spinraza方案

2026-03-31 00:07

The US FDA has approved a high-dose regimen of Biogen's (BIIB) spinal muscular atrophy treatment Spinraza (nusinersen) consisting of 50 mg/5 mL and 28 mg/5 mL doses.
Biogen said that the new regimen allows for an accelerated loading phase for individuals new to treatment composed of two 50 mg doses given 14 days apart, followed by 28 mg maintenance dose injections every four months thereafter.
Those switching from the low-dose regimen would follow their current dosing schedule at every four months after a single high-dose loading phase.
Approval was supported by results from the phase 2/3 DEVOTE study.

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