FDA requests update to technical information of Biogen nusinersen sNDA

Biogen (BIIB) announced that the FDA issued a complete response letter for the company’s supplemental new drug application for the high dose regimen of nusinersen for the treatment of spinal muscular atrophy. The FDA letter requested an update to the technical information be included in the chemistry manufacturing and controls module of the sNDA. The letter did not cite any deficiencies in the clinical data of the high dose regimen. The FDA provided options for resolution, and Biogen is planning to resubmit the application promptly based upon readily available information. “While this outcome was unexpected, we remain committed to bringing the high dose regimen to people living with SMA,” said Priya Singhal, head of development at Biogen. “We are working diligently to provide the necessary information to the FDA.”