The US Food and Drug Administration has issued a green light for MT Pharma America’s Radicav, opening the door to the first new therapy for amyotrophic lateral sclerosis (ALS) in more than 20 years.
As many as 30,000 Americans may be affected by ALS, also referred to as Lou Gehrig's disease, a neuromuscular condition that attacks nerve cells in the brain and spinal cord responsible for controlling voluntary muscles, such as those needed to move, speak, eat and breathe.
The condition is inherited in 5 percent to 10 percent of cases, but the cause for the majority of cases is not well understood, and there is currently no cure.
Edaravone (MCI-186) 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.
The drug’s approval was based on Phase III trials showing that people given Radicava showed significantly less decline - by 33 percent - in physical function compared to placebo as measured by the ALS Functional Rating Scale-Revised (ALSFRS-R), the firm noted.
“We believe Radicava offers new hope for people with ALS and exemplifies MT Pharma America’s commitment to innovative therapies for patients in the US battling life-threatening diseases,” said Atsushi Fujimoto, president, MT Pharma America. “We recognise how important this therapy may be to people with ALS and are committed to helping provide access to this important treatment option, with the goal of keeping out-of-pocket costs at a minimum for eligible patients.”
“The approval of Radicava brings us into a new era of treatment by evolving how we manage this complex disease,” noted Jonathan Katz, ALS clinic director, Forbes Norris MDA/ALS Research and Treatment Center at California Pacific Medical Center. “This is an uplifting milestone for the ALS community especially since it’s been so long since we had anything new.”
Edaravone was discovered and developed for ALS by Mitsubishi Tanabe Pharma Corporation.