FDA Extends Review Time for Biogen's ALS Therapy.

PROTEINS; GENETIC mutation; LIFE expectancy; INVESTIGATIONAL drugs; SUPEROXIDE dismutase; UNITED States. Food & Drug Administration; AMYOTROPHIC lateral sclerosis

The article reports that the U.S. Food and Drug Adminstration (FDA) has extended the review of tofersen, an antisense drug, to treat patients with superoxide dismutase 1 (SOD1) amyotrophic lateral sclerosis (ALS). It informs that the drug is developed by Ionis Pharmaceuticals and licensed to Biogen. It also informs that Biogen's new drug Application (NDA) was accepted by the FDA in July 2022.