FDA Approves Radicava for Amyotrophic Lateral Sclerosis
MONDAY, May 8, 2017 -- The first new drug to treat amyotrophic lateral sclerosis (ALS) in more than 20 years has been approved by the U.S. Food and Drug Administration.
Radicava (edaravone) is taken intravenously daily for 14 days, followed by 14 days without the drug. Subsequent treatment cycles consist of treatment for 10 out of 14 days, followed by 14 days without the drug.
The FDA's approval of Radicava was based on a six-month clinical trial in Japan that included 137 patients who received either the drug or an inactive placebo, the agency said. After 24 weeks, patients taking the drug had less decline in physical functioning than those taking the placebo. The most common side effects among patients taking the drug were bruising and gait disturbance.
"Radicava is also associated with serious risks that require immediate medical care, such as hives, swelling, or shortness of breath, and allergic reactions to sodium bisulfite, an ingredient in the drug," the agency said in the news release. "Sodium bisulfite may cause anaphylactic symptoms that can be life-threatening in people with sulfite sensitivity."
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Posted: May 2017