Posted by Michael Wonder on 26 Sep 2016
Biogen completes rolling submission of new drug application to FDA for nusinersen as a treatment for spinal muscular atrophy
26 September 2016 - Submission of marketing authorization application to the EMA planned in the coming weeks.
Biogen and Ionis today announced that Biogen has completed the rolling submission of a New Drug Application (NDA) to the U.S. FDA for the approval of nusinersen, an investigational treatment for spinal muscular atrophy (SMA). Biogen has also applied for Priority Review which, if granted, would shorten the review period of nusinersen following the Agency’s acceptance of the NDA.
In addition to the NDA filing with FDA, Biogen plans to submit a Marketing Authorization Application (MAA) for nusinersen to the EMA in the coming weeks. The EMA’s Committee for Medicinal Products for Human Use recently granted accelerated assessment to nusinersen, which can reduce the standard review time. Biogen will initiate regulatory filings in other countries in the coming months.
