Biogen gets CRL for high dose nusinersen

The US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for biotech major Biogen’s (Nasdaq: BIIB) supplemental New Drug Application (sNDA) for the high dose regimen of nusinersen for the treatment of spinal muscular atrophy (SMA).

The FDA letter requested an update to the technical information be included in the Chemistry Manufacturing and Controls (CMC) module of the sNDA. Market reaction was mute, with Biogen’s shares closing down just less than 1%.’

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.