Posted by Michael Wonder on 26 Jul 2022
Ionis announces that FDA accepts new drug application and grants priority review of tofersen for a rare, genetic form of ALS
26 July 2022 - 12 month data included in the filing show that earlier initiation of tofersen slowed decline across measures of clinical and respiratory function, strength, and quality of life; tofersen also led to robust and sustained reductions in neurofilament, a marker of neurodegeneration.
Ionis Pharmaceuticals today announced that the U.S. FDA has accepted a new drug application for tofersen, an investigational antisense medicine for the treatment of superoxide dismutase 1 amyotrophic lateral sclerosis.
