Biogen also plans to submit a Marketing Authorization Application to the European Medicines Agency (EMA).
Spinal muscular atrophy (SMA) is a serious muscle wasting condition caused by the deterioration of nerves cells connecting the brain and the spinal cord to the body’s muscles.
The EMA’s Committee for Medicinal Products for Human Use recently granted “accelerated assessment” to nusinersen, cutting the standard review time.
Biogen said it will initiate regulatory filings in other regions in the coming months.
“We appreciate the FDA’s collaboration with us during the application process, and we look forward to continuing this productive dialogue, with the goal of rapidly bringing the first treatment for SMA to as many patients as possible.”