FDA accepts new drug application, grants priority review for ALS treatment

Biogen Inc. announced that the FDA has accepted a new drug application for tofersen, an investigational drug to treat superoxide dismutase 1 ALS.
According to a company press release, superoxide dismutase 1 (SOD1) ALS is a rare, genetic form of the disease. While average life expectancy for people with ALS is 3 to 5 years from symptom onset, some patients with SOD1 ALS survive less than a year.
Biogen’s application for tofersen, which would be the first treatment to target a genetic cause of ALS, was granted priority review and given a Prescription Drug User Fee Act action date of Jan.

Biogen Inc. announced that the FDA has accepted a new drug application for tofersen, an investigational drug to treat superoxide dismutase 1 ALS.
According to a company press release, superoxide dismutase 1 (SOD1) ALS is a rare, genetic form of the disease. While average life expectancy for people with ALS is 3 to 5 years from symptom onset, some patients with SOD1 ALS survive less than a year.
Biogen’s application for tofersen, which would be the first treatment to target a genetic cause of ALS, was granted priority review and given a Prescription Drug User Fee Act action date of Jan.