FDA has approved edaravone (Radicava—Mitsubishi Tanabe Pharma America) for the treatment of patients with amyotrophic lateral sclerosis (ALS), also referred to as Lou Gehrig's disease. "After learning about the use of edaravone to treat ALS in Japan, we rapidly engaged with the drug developer about filing a marketing application in the United States," said Eric Bastings, MD, deputy director of the Division of Neurology Products in FDA's Center for Drug Evaluation and Research. "This is the first new treatment approved by the FDA for ALS in many years, and we are pleased that people with ALS will now have an additional option." Edaravone—an I.V. infusion given by a health care professional—is administered with an initial treatment cycle of daily dosing for 14 days, followed by a 14-day drug-free period. Subsequent treatment cycles feature dosing on 10 of 14 days, followed by 14 drug-free days. A 6-month clinical trial involving 137 patients in Japan demonstrated the efficacy of edaravone. At 24 weeks, patients who received edaravone declined less on a clinical assessment of daily functioning compared with those receiving a placebo. The most frequent adverse reactions reported by clinical trial participants who took edaravone included bruising and gait disturbance. Edaravone is also associated with serious risks that require immediate medical attention, including hives, swelling, or shortness of breath, and allergic reactions to sodium bisulfite, an ingredient in the drug.