Biogen submits nusinersen NDA

Biogen Inc. (NASDAQ:BIIB) completed submission of a rolling NDA to FDA for nusinersen ( IONIS-SMNRx) to treat spinal muscular atrophy (SMA). The company requested Priority Review for nusinersen, an antisense oligonucleotide that modulates splicing of survival of motor neuron 2 centromeric ( SMN2) mRNA.

Last month, Biogen exercised an exclusive option to obtain worldwide rights to nusinersen after Ionis Pharmaceuticals Inc. (NASDAQ:IONS) said the therapy met a co-primary endpoint in the Phase III ENDEAR study to treat infantile-onset SMA (see BioCentury Extra, Aug. 1). ...