FDA Approves New Treatment for ALS

The US Food and Drug Administration recently approved Radicava (edaravone) for the treatment of amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig disease.

Radicava is an intravenous infusion administered daily for 14 days by a health care professional at initiation of treatment, followed by a 14-day drug-free period. After initiation, Radicava is administered daily for 10 days out of the 14-day cycle, followed by a 14-day drug-free period.
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The safety and efficacy of Radicava was demonstrated in a 6-month clinical trial conducted in Japan that included 137 participants randomly assigned to receive Radicava or placebo. Individuals who took Radicava showed less decline on a clinical assessment of daily functioning at 24 weeks compared with participants who received the placebo.

Common adverse reactions observed in participants taking Radicava included contusion and gait disturbance. In addition, serious adverse events that required immediate medical care included hives, swelling, shortness of breath, and allergic reactions to sodium bisulfite.

—Melissa Weiss

Reference:

FDA approves drug to treat ALS [press release]. FDA. May 5, 2017. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm557102.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery.