Biogen Gets Priority Review from FDA for ALS Drug

Biogen has another chance at approval by the US Food and Drug Administration for its amyotrophic lateral sclerosis (ALS) drug tofersen. A phase III trial for the drug in the treatment of ALS failed last October, but the data showed that it was effective for patients with a subset of the disorder called SOD1-ALS. It is on this basis that the FDA has granted priority review of the drug.

According to Emily Kimber, “Timothy Miller, principal investigator of VALOR and ALS Center co-director at Washington University School of Medicine, said: “The 12-month results showed that individuals with SOD1-ALS who started tofersen earlier experienced a slower rate of decline in clinical and respiratory function, strength and quality of life. These are critical measures for people living with this devastating disease.”

To read more, click here.

(Source: PM Live, July 27th, 2022)