First New Treatment for ALS in More Than 20 Years Approved by FDA

By | May 11, 2017

MT Pharma America announced that the FDA has granted approval of Radicava (edaravone) to treat amyotrophic lateral sclerosis (ALS). ALS is a rapidly progressive neurodegenerative disease – the majority of patients die within two to five years of diagnosis. An estimated 6,000 Americans are diagnosed each year with ALS, an incurable disease that affects the nerve cells in the brain and spinal cord. Initial symptoms can be subtle at first, and it can take 12 to 14 months to be accurately diagnosed with ALS. The clinical development program for Radicava in ALS spanned 13 years and included multiple Phase 3 trials. The pivotal Phase 3 study, which formed the basis for the FDA approval, demonstrated patients who received Radicava for six months experienced 33% less decline in physical function.

Edaravone was discovered and developed for ALS by Mitsubishi Tanabe Pharma Corporation (MTPC) and will be commercialized in the U.S. by MT Pharma America. MTPC group companies began researching ALS in 2001. In 2015, edaravone was approved for use as a treatment for ALS in Japan and South Korea. (Source: MT Pharma America Website)

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