Its has been three years since Ice bucket challenge went viral promoting awareness of amyotrophic lateral sclerosis (ALS), commonly referred to as Lou Gehrig’s disease and encourage donations to research.
Three years later, the FDA has answered the challenge again by giving approval for MT Pharma America’s (MTPA) Radicava (edaravone) to treat patients with ALS.
ALS is a rare disease that attacks and kills the nerve cells that control voluntary muscles. The Centers for Disease Control and Prevention estimates that approximately 12,000-15,000 Americans have ALS.
Radicava is an intravenous infusion given by a health care professional. MTPA said that, according to its research, people given Radicava showed significantly less decline in physical function compared to placebo as measured by the ALS Functional Rating Scale-Revised (ALSFRS-R), a validated rating instrument for monitoring the progression of disability in patients with ALS.
Eric Bastings, M.D., deputy director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research noted that this is the first new treatment approved by the FDA for ALS in many years.
Jonathan S. Katz, M.D., ALS Clinic Director, Forbes Norris MDA/ALS Research and Treatment Center at California Pacific Medical Center said: “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.”