FDA approves the first new drug to treat "gradually frozen people" in years

• by EVOMT
• 2017-06-05

　　On May 5th, the FDA and local time approved Radicava (edaravone) for the treatment of patients with amyotrophic lateral sclerosis (ALS), commonly known as "gradually frozen people." This is the first new treatment for ALS approved in the United States in more than 20 years. Prior to this, the FDA had granted the drug orphan drug certification

　　"After learning that Edaravone was used to treat patients with ALS in Japan, we quickly contacted the drug developer to discuss the application for marketing in the United States," said Dr. Eric Bastings, deputy director of the Neurological Products Department of the FDA Drug Evaluation and Research Center. "This is the first new treatment for ALS approved in the United States for many years, and we are pleased that ALS patients have new treatment options."

　　ALS is a rare disease that attacks and kills nerve cells that control involuntary muscles, which can produce actions such as chewing, walking, and breathing. If nerve damage fails to activate specific muscles, these muscles can also become increasingly weak and cause paralysis. ALS is progressive, which means that the condition will become increasingly severe. According to the prediction of the American Center for Disease Control and Prevention, About 12000 to 15000 people in the United States have ALS. Most patients with ALS usually die of respiratory failure within 3-5 years after their symptoms first appear

　　Edaravone is administered intravenously by professional medical personnel. The first treatment cycle is to receive medication daily for 14 days, followed by withdrawal for 14 days. The subsequent treatment cycle is to receive medication for 10 days of 14 days, followed by withdrawal for 14 days

　　The effectiveness of Edaravone in treating ALS was demonstrated in a 6-month clinical trial conducted in Japan, where a total of 137 subjects were randomly assigned to receive Edaravone or placebo treatment. At the 24th week, it was found that patients receiving Edaravone treatment had less deterioration in their daily functioning compared to the placebo group

　　The most common adverse reactions reported by subjects with Edaravone are bruising and unstable gait. Edaravone can also pose a serious risk and require immediate medical treatment, such as urticaria, edema, or shortness of breath, as well as an allergic reaction to the drug ingredient sodium bisulfite. Patients who are allergic to sulfite may experience fatal allergic symptoms