Mitsubishi Tanabe Pharma Corporation announced that the US Food and Drug Administration (FDA) has accepted the company's New Drug Application (NDA) for edaravone (MCI-186), an intravenous treatment for amyotrophic lateral sclerosis (ALS), a rapidly progressive neurological disease. A decision on the application is anticipated on June 16, 2017 based on the Prescription Drug User Fee Act. If approved, the medicine will be commercialized, under the brand name Radicava, through the newly-formed MT Pharma America, Inc.

"This is an important milestone for Mitsubishi Tanabe Pharma and for the US ALS community," said Joseph M. Palumbo, MD, vice president, head of clinical research, Mitsubishi Tanabe Pharma Development America, Inc. "There is an urgent need for new treatment options in ALS and we are now an important step closer to potentially making that a reality. We look forward to working with the FDA as part of the review process."

ALS, sometimes called Lou Gehrig's disease, attacks the nerve cells in the brain and the spinal cord responsible for controlling voluntary muscles, such as those needed to move, speak, eat and breathe. It is one of the most well-known neuromuscular diseases, affecting approximately two in 100,000 people worldwide. While it is inherited in 5%10% of cases, the cause for the majority of cases is not well understood but may involve genetic and environmental factors. There is currently no cure.

The edaravone NDA is supported by a clinical research program in patients diagnosed with ALS in Japan. In 2015, edaravone was approved for use as a treatment for ALS in Japan and South Korea. In the same year, the FDA and the European Commission granted Orphan Drug Designation for edaravone. It is not currently approved by the FDA for any use in the US.

Discovered by Mitsubishi Tanabe Pharma Corporation, edaravone is described as a free radical scavenger that is believed to relieve the effects of oxidative stress, a likely factor in the onset and progression of ALS. Oxidative stress is thought to be an imbalance between the production of free radicals and the ability of the body to counteract or detoxify their harmful effects. In patients with ALS, there are consistent increases in oxidative stress biomarkers.