Clinigen and Mitsubishi Tanabe Initiate European Managed Access Program for Edaravone to Treat ALS

the global pharmaceutical and services company, has partnered with Mitsubishi Tanabe Pharma Corporation (‘MTPC’), to initiate a Managed Access Program (also known as an Early Access Program) in Europe for edaravone, an intravenous treatment for amyotrophic lateral sclerosis (‘ALS’).

Edaravone is approved for use as a treatment for ALS in Japan, South Korea and the USA.

ALS is an idiopathic neurodegenerative disease in which motor neurons selectively degenerate and vanish. Muscle strength declines throughout the entire body, including the limb, facial, and respiratory muscles, and muscular atrophy progress. The cause for the majority of cases is not well understood, but may involve genetic and environmental factors. It is one of the best known neuromuscular diseases and affects approximately two in 100,000 people worldwide.

John Lagus, Head of Managed Access, Clinigen, said:

"We are pleased to once again be working with MTPC to help eligible patients in Europe gain access to this important medicine.

"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."

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