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FDA Approves Drug to Treat ALS

FDA news release; 2017 May 5

The US Food and Drug Administration (FDA) has approved Radicava (edaravone) to treat patients with amyotrophic lateral sclerosis (ALS), commonly referred to as Lou Gehrig’s disease. ALS is a rare, progressive disease that attacks and kills the nerve cells that control voluntary muscles, which produce movements such as chewing, walking, breathing, and talking. Most people with ALS die from respiratory failure, usually within 3 to 5 years from when the symptoms first appear. Radicava is manufactured by Mitsubishi Tanabe Pharma America, Inc., headquartered in Jersey City, NJ.

Indications: Radicava is an intravenous infusion given by a health care professional. It is administered with an initial treatment cycle of daily dosing for 14 days, followed by a 14-day drug-free period. Subsequent treatment cycles consist of dosing on 10 of 14 days, followed by 14 days drug-free.

Dosage/administration: The recommended dosage is 60 mg administered as an intravenous infusion over 60 minutes.

Adverse effects: Most common adverse reactions (at least 10% and greater than placebo) are contusion, gait disturbance, and headache.

Citation:

US Food and Drug Administration. FDA approves drug to treat ALS. FDA Web site. May 5, 2017. https://www.fda.gov/newsevents/newsroom/pressannouncements/ucm557102.htm. Accessed May 16, 2017.