The US Food and Drug Administration (FDA) has accepted Biogen’s (Nasdaq: BIIB) supplemental New Drug Application (sNDA) and the European Medicines Agency (EMA) has validated the application for a higher dose regimen of nusinersen, marketed as Spinraza, for spinal muscular atrophy (SMA).
The higher dose regimen of nusinersen comprises a more rapid loading regimen, two 50mg doses 14 days apart, and higher maintenance regimen, 28mg, every four months, compared to the approved nusinersen regimen.
“We are pleased to announce that our applications for the higher dose regimen of nusinersen are now under review in the US and Europe,” said Stephanie Fradette, head of the Neuromuscular Development Unit at Biogen. “This milestone reflects our steadfast commitment to advance treatment options for individuals with SMA, and we expect that this higher dose regimen will offer meaningful benefits to patients and their families. We are deeply thankful for the unwavering support of the trial participants, their families, site staff, and the SMA community without whom these advancements would not have been possible,” she added.
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