Status of Edaravone Marketing Authorization in the European Union
May 30, 2019
Mitsubishi Tanabe Pharma Corporation (MTPC) has made the difficult decision to withdraw its Marketing Authorization Application (MAA) for edaravone as a treatment for Amyotrophic Lateral Sclerosis (ALS) from consideration by the European Medicines Agency (EMA).
This decision is based on regulatory requirements specific to the EMA and does not impact the approval status or availability of edaravone in the United States.
Mitsubishi Tanabe Pharma group companies remain fully confident in the available scientific data from edaravone studies and the important benefit this treatment has been shown to provide for the slowing of functional loss in ALS. Edaravone has been reviewed and approved by multiple regulatory bodies around the world, including Japan, South Korea, United States, Canada and Switzerland.
An EMA regulatory approval would have required an additional one-year placebo-controlled clinical trial to investigate survival. We believe it is not in the patient’s best interest to place a person who has a rapidly progressive, fatal disease on a placebo when edaravone already has been shown in a clinical trial to slow the loss of physical function by 33 percent, as measured by the ALSFRS-R.
This decision does not affect the approval status of edaravone in the United States. Patients with questions about their treatment should speak with their doctor. Searchlight Support® is also available for product access-related questions at 1-844-SRCHLGT (1-844-772-4548).
The MTPC press release can be viewed here.
Mitsubishi Tanabe Pharma America, Inc.