FDA Approves ALS Treatment

MAY 06, 2017
The FDA has approved edaravone (Radicava, Mitsubishi Tanabe Pharma America) for the treatment of amyotrophic lateral sclerosis (ALS), the first new ALS therapy approved by the FDA in several years.
 
Radicava is an intravenous infusion administered with an initial treatment cycle of daily dosing for 14 days, followed by a 14-day drug free period. Subsequent treatment cycles include dosing on 10 of those 14 days, followed by the 14-day drug free period.
 
The approval is based on a 6-month clinical trial conducted in Japan that demonstrated edavarone’s efficacy as a treatment for ALS. The trial included 137 participants who were randomly assigned to receive either edavarone or placebo. People who received edavarone showed less decline in daily functioning than those receiving a placebo.
 
The most common adverse effects include bruising and gait disturbance. The drug has also been associated with hives, swelling, shortness of breath, and allergic reactions to sodium bisulfite.
 
Reference
 
FDA approves drug to treat ALS [news release]. FDA’s website. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm557102.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery. Accessed May 6, 2017.
 
 

SHARE THIS SHARE THIS
1

Become a Respimat Top Performer 

Get to know RESPIMAT, the slow-moving mist inhaler from Boehringer Ingelheim Pharmaceuticals, Inc. 

Watch the RESPIMAT video and test your knowledge with a short multiple-choice quiz. When you get all the answers right, you’ll receive a certificate naming you a RESPIMAT T.O.P. Performer. Why not check it out today? 

 

Pharmacy Times Strategic Alliance
 

Pharmacist Education
Clinical features with downloadable PDFs


Next-Generation Pharmacist® Awards


3rd Annual Convenient Healthcare and Pharmacy Collaborative Conference


SIGN UP FOR THE PHARMACY TIMES NEWSLETTER
Personalize the information you receive by selecting targeted content and special offers.