Thursday, Biogen Inc. (BIIB) announced that the U.S. Food and Drug Administration has granted salanersen Breakthrough Therapy Designation for the treatment of spinal muscular atrophy or SMA.
Salanersen is an investigational novel antisense oligonucleotide and has the potential to offer high efficacy in SMA with once-yearly dosing.
The decision is based on findings from the Phase 1b study of salanersen, which demonstrated clinically meaningful improvements in motor function as well as slowing of neurodegeneration in children with SMA who had a suboptimal response to prior gene therapy.
Stephanie Fradette, Head of the Rare Neurology Development Unit at Biogen, said, "This is a significant milestone for our SMA portfolio as we advance the Phase 3 studies designed to establish the role of salanersen in the future SMA treatment landscape."
In the pre-market hours, BIIB is trading at $198.00, up 1.04 percent on the Nasdaq.
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