Clinigen, Mitsubishi Tanabe Announce Early Access Program in Europe for ALS Therapy Radicava

Margarida Azevedo, MSc avatar

by Margarida Azevedo, MSc |

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Clinigen Group recently partnered with Mitsubishi Tanabe Pharma Corporation to launch an early access program in Europe for Radicava (edaravone), an intravenous treatment for amyotrophic lateral sclerosis (ALS).

The therapy is not yet approved in Europe, but the early access program will help make it available to patients who may benefit from it before its commercial launch.

“We are pleased to once again be working with MTPC to help eligible patients in Europe gain access to this important medicine,” John Lagus, head of managed access at Clinigen, said in a press release. “As the trusted global leader in access to unlicensed medicines, this partnership aligns with our mission of getting the right medicines to the right patient at the right time.”

Edaravone is already approved as an ALS treatment in Japan, South Korea, and the United States, where it is marketed by Mitsubishi Tanabe as Radicava.

In April 2018, Health Canada accepted Mitsubishi Tanabe’s new drug submission for edaravone, granting it priority review in the process.

Edaravone is a free radical scavenger, meaning it helps to remove free radicals from the nervous system. Free radicals occur as a normal part of a cell’s energy production process and are typically removed by the body; however, if they are not removed quickly enough, they can cause oxidative stress, which is believed to be one of the causes of nerve cell death in ALS.

In clinical trials, edaravone has performed well. In a Phase 3 trial (NCT01492686) evaluating the effectiveness and safety of edaravone in ALS patients, those on the therapy experienced 33 percent less decline in their revised ALS functional rating scale (ALSFRS-R) scores than those in the placebo group, after six months of treatment.

These results were considered statistically significant and were later published in the journal The Lancet Neurology.

In May 2017, the infusion treatment became the first ALS therapy in 22 years to receive approval from the U.S. Food and Drug Administration.

Radicava was described as a “minor miracle” for some ALS patients by Stephen Byer, co-director of ALS Worldwide, in a 2017 interview with ALS News Today.

“We have found and continue to find great benefit in terms of slowing, stopping and, in some cases, even helping to mildly reverse some symptoms of the disease,” he said at the time.