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FDA approves Spinraza in SMA

December 23, 2016 11:24 PM UTC

FDA approved Spinraza nusinersen from Biogen Inc. (NASDAQ:BIIB) and Ionis Pharmaceuticals Inc. (NASDAQ:IONS) to treat children and adults with spinal muscular atrophy (SMA). It is the first drug approved for the indication.

Biogen received a pediatric rare disease Priority Review voucher with the approval, and paid a $60 million milestone payment to Ionis. In August, Ionis received $75 million when Biogen exercised its option for worldwide rights to Spinraza after the therapy met a co-primary endpoint in a Phase III study to treat infantile-onset SMA (see BioCentury Extra, August 1)...