MT Pharma America has secured the US Food and Drug Administration (FDA) approval for Radicava (edaravone) as an intravenous infusion treatment for patients affected with amyotrophic lateral sclerosis (ALS).
ALS is a rapidly progressive neurodegenerative disease and most of the affected patients die within two to five years of diagnosis.
The company stated that patients treated with Radicava exhibited substantially less decline in physical function compared to placebo, as measured by the ALS Functional Rating Scale-Revised (ALSFRS-R), an instrument used to monitor the progression of disability in patients with ALS.
MT Pharma America president Atsushi Fujimoto said: “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.
“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.”
Every year, about 5,000-6,000 Americans are affected with ALS, which affects the nerve cells in the brain and spinal cord.
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It may take more than 12 months to be accurately diagnosed with ALS.
California Pacific Medical Center ALS clinic director Jonathan Katz said: “For people with ALS and their families, having a new therapy which slows the decline of physical ability is incredibly significant.
“The approval of Radicava brings us into a new era of treatment by evolving how we manage this complex disease.
“This is an uplifting milestone for the ALS community, especially since it’s been so long since we had anything new.”
The clinical development programme for Radicava in ALS lasted 13 years, including multiple Phase III trials.
FDA provided the approval on the basis of the pivotal Phase III study (MCI186-19), which assessed 137 patients with ALS.
The analysis revealed that people who received Radicava for six months experienced a significantly less deterioration of physical function by nearly 33% or 2.49 ALSFRS-R points.