JERSEY CITY, N.J. — The first drug for ALS approved in 22 years is now available. Mitsubishi Tanabe Pharma America this week announced the introduction of its Radicava (edaravone), an intravenous treatment for ALS that the Food and Drug Administration approved on May 5.
“After 13 years of clinical research and investment, we have reached a seminal moment, which may shift the treatment paradigm for this terrible disease," Mitsubishi Tanabe Pharma America chief commercial officer Tom Larson said. “As of today, all across the country, conversations between ALS specialists and patients may be substantially different. We are all extremely proud and excited to be a part of bringing Radicava and new hope to patients in the U.S.”
In clinical trials, 33% of patients treated with Radicava showed a lower rate of decline in the loss of physical function, compared with those on a placebo. Currently, between 5,000 and 6,000 patients are diagnosed with ALS every year.
"This new treatment may give hope to every person suffering from ALS, and we pray the positive result from this trial will set the tone for more therapies going forward. We all remain committed," said Dr. Jonathan Katz, ALS Clinic Director of the Forbes Norris MDA/ALS Research and Treatment at California Pacific Medical Center.