Second ALS treatment approved

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Food and Drug Administration approved the first new medication for the treatment for amyotrophic lateral sclerosis (ALS), which is commonly known as Lou Gehrig’s disease, in 22 years.

Edaravone, which is marketed as Radicava by Mitsubishi Tanabe Pharma America, is an intravenous medication that’s administered by a health-care professional. It’s administered through an initial cycle of daily dosing for 14 days that’s followed by 14 days off. Subsequent treatment cycles consist of dosing for 10 of 14 days and then 14 days off.

ALS is a rare disease that attacks and kills the nerve cells that control voluntary muscles. It’s progressive, which means that it gets worse over time. Most people who have ALS die from respiratory failure within 3–5 years of developing symptoms. The only other FDA-approved medication for ALS, riluzole, was approved in 1995.

Common adverse reactions to edaravone in clinical-trial participants included bruising and gait disturbance. The medication also is associated with serious risks that require immediate medical care, such as hives, swelling and shortness of breath.