FDA approves first new drug in 20 years to treat ALS

The US Food and Drug Administration on Friday approved Radicava (edaravone) to treat patients with amyotrophic lateral sclerosis (ALS), commonly referred to as Lou Gehrig’s disease.

The approval of Radicava was granted to MT Pharma America, a US subsidiary of Japanese drug major Mitsubishi Tanabe Pharma (TYO: 4508), which filed its New Drug Application for the drug in June last year, and marks the first clearance for marketing of an ALS drug in around 20 year..

“After learning about the use of edaravone to treat ALS in Japan, we rapidly engaged with the drug developer about filing a marketing application in the United States,” said Eric Bastings, deputy director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research. “This is the first new treatment approved by the FDA for ALS in many years, and we are pleased that people with ALS will now have an additional option,” Dr Bastings added.