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ALS Worldwide
March 27, 2017

Masitinib & Edaravone: Two Proven ALS Drugs Await Simultaneous FDA Approval

The French Biotech AB Science has announced positive results of a final Phase III trial analyzing its lead asset masitinib in patients with amyotrophic lateral sclerosis (ALS).

"This is very good news for the patients. These final data confirm findings from the study’s interim analysis and proves that masitinib is capable of slowing down motoneuron degenerative disease such as ALS, which is a devastating condition with an urgent unmet medical need," said Alain Moussy, CEO of AB Science.

AB Science is a pharmaceutical company specializing in the clinical development of protein kinase inhibitors. Its lead asset, masitinib, is in clinical development for several indications and has now passed a final Phase III study revealing the efficacy and safety of masitinib in patients with ALS. AB Science was already granted Orphan Drug Designation for masitinib by both FDA and EMA and filed for marketing authorization at the EMA in September 2016.

The compound is an orally administered protein kinase inhibitor, which targets mast cells and macrophages by inhibiting a number of protein kinases within these cells. In the brain, the inhibitor also targets microglia, the resident macrophages of the brain, and can thereby inhibit inflammatory processes within the central nervous system.

Based on the high medical need, several competitors are also working on new treatments for ALS. The FDA recently accepted an NDA filed by Mitsubishi Tanabe Pharma for Edaravone. This drug is a free radical scavenger, which has passed phase III trials for ALS last year. The FDA decision on the new compound is expected this summer.

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ALS Worldwide has closely studied and monitored Masitinib and Edaravone over the past several years. In fifteen years' time, we have yet to come across one, yet alone two treatments with the potential to have such an enormously positive, direct impact on the wellbeing of ALS patients.

Based on our enthusiasm and conviction, we have strongly advocated FDA to utilize the priority-review process and the accelerated-approval program to make available as quickly as possible these promising drugs to those affected by ALS.

You can make a tangible impact and hopefully accelerate FDA approval of these critically needed ALS drugs by lending your voice to the cause.

Please contact FDA with a message like, “I join ALS Worldwide and the community of ALS advocates in urging FDA to approve the drugs Masitinib and Edaravone as quickly as possible for the immediate benefit of those suffering from this devastating disease.”

You may reach FDA's Center for Drug Evaluation and Research by phone at 1-855-543-3784 (or 1-301-796-3400), Monday through Friday from 8:00 a.m. to 4:30 p.m. (Eastern Standard Time) or by email, [email protected]. You can also write directly to FDA at: Division of Drug Information, 10001 New Hampshire Avenue, Hillandale Building - 4th Floor, Silver Spring, MD 20993.

Contact us at [email protected], if you have any questions, viewpoints, or additional thoughts.