What You Need to Know About Radicava for ALS


The first new FDA approval for ALS in 22 years, here's what you should know.

The FDA approved edaravone (Radicava, Mitsubishi Tanabe Pharma America) on Friday, May 5, 2017 for the treatment of amytrophic lateral sclerosis (ALS) also known as Lou Gehrig's Disease.1 The approval is only the second medication approved for the indication, with riluzole (Rilutek) being approved in 1995. Radicava has been available in Japan and Korea since 2015.1

The approval is based on a 24-week, phase 3 double-blind, parallel-group study comparing edaravone to placebo. The primary outcome was functioning as defined by ALS Functional Rating Scale-Revised (ALSFRS-R).2 The ALSFRS-R evaluates functional abilities such as swallowing and speech, and higher scores are associated with higher functioning. The trial results showed ALS patients treated with edaravone had less functional loss at 6 months compared to the placebo group with a between group difference of 2.49 +/- 0.76 (P = .001). It is important to note none of the trials for edaravone in ALS have yet to evaluate the effect on survival.

Radicava is an intravenous treatment given as 60 mg daily for a 14-day cycle followed by a 14-day drug-free period. Subsequent cycles administer Radicava daily for 10 days over a 14-day period followed by a 14-day drug-free period again.3*The mechanism of edaravone in ALS is not well understood but hypothesized to be related to oxidative stress on vascular endothelial cells and nerve cells. Renal function and hepatic function should be closely monitored while patients receive treatment with edaravone. The most common adverse events are bruising and gait disturbance.

Rare but significant adverse events include hives, swelling, anaphylaxis due to the inclusion of sodium bisulfite in patients with a sulfite allergy.

1. 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 8, 2017.

2. Tanaka M, et al. A 24-week, phase III, double-blind, parallel-group study of edaravone (MCI-186) for treatment of Amytrophic Lateral Sclerosis. Neurology. 2016; (86):16. SP3 189.

3. Radicut(R) [Package Insert]. Osaka, Japan. Mitsubishi Tanabe Pharma Corporation; June 2015.

Related Videos
Laboratory test tubes and solution with stethoscope background | Image Credit: Shutter2U - stock.adobe.com
Image credit: Andrea Izzotti
Human brain digital illustration. Electrical activity, flashes, and lightning on a blue background. | Image Credit: Siarhei - stock.adobe.com
Inflation Reduction Act is shown using the text and the US flag - Image credit: Andrii | stock.adobe.com
Pharmacy Interior | Image Credit: Tyler Olson - stock.adobe.com
Male pharmacist selling medications at drugstore to a senior woman customer | Image Credit: Zamrznuti tonovi - stock.adobe.com
Pharmacist assists senior woman in buying medicine in pharmacy - Image credit: Drazen | stock.adobe.com
Pharmacy, medicine and senior woman consulting pharmacist on prescription. Healthcare, shopping and elderly female in consultation with medical worker for medication box, pills or product in store - Image credit: C Daniels/peopleimages.com | stock.adobe.com
Image credit: fidaolga - stock.adobe.com
Pharmacists checking inventory at hospital pharmacy- Image credit: Jacob Lund | stock.adobe.com
© 2023 MJH Life Sciences

All rights reserved.