BREAKING NEWS – Radicava Approved to Treat ALS/MND in the USA

On May 5, 2017, the US Food and Drug Administration (FDA) approved the drug Radicava (edaravone) for the treatment of ALS/MND patients in the United States.

Background

The compound edaravone was developed by Mitsubishi Tanabe Pharma Corporation in Japan. Edaravone was originally marketed for use in stroke patients. Later, the company decided to test edaravone in people with ALS/MND. After a series of Phase 3 trials in Japan, in 2015, regulatory bodies approved edaravone to treat people with ALS/MND in Japan and South Korea. Edaravone is marketed under the brand name “Radicut” in Japan and South Korea.

In June of 2016, MT Pharma America submitted an application to the FDA for regulatory approval in the US. This application was approved by the FDA May 5, 2017. Edaravone will be marketed as “Radicava” in the US and will be distributed commercially by MT Pharma America.

How Does Edaravone Work?

Edaravone is thought to protect cells from oxidative stress. Oxidative stress occurs when the body produces too many free radicals and can’t effectively counteract their effects with antioxidants. Preventing oxidative stress may help to prevent motor neuron death in people with ALS/MND.

How Is It Administered?

Edaravone is administered by intravenous injection. This explanation comes directly from MT Pharma America’s website:

RADICAVA is administered in 28-day cycles by intravenous infusion. It takes 60 minutes to receive each 60 mg dose. For the initial cycle, the treatment is infused daily for 14 consecutive days, followed by a two-week drug-free period. All cycles thereafter are infused daily for 10 days within a 14-day period, followed by a two-week drug-free period.

How Effective Is It?

Mitsubishi Tanabe conducted its final Phase 3 study in Japan with 137 ALS patients. According to data made public by MT Pharma America, during this six-month trial, the group of people given edaravone showed a 33% improvement in their ALSFRS-R scores, as compared to those given placebo.

All of the patients in this study began using edaravone early in their disease progress (soon after diagnosis). The most common side effects were headache, trouble walking and bruising at the site of injection. In a very small number of patients, hypersensitivity or allergic reactions did occur, which could be life-threatening. Learn more at www.radicava.com.

Who Will Be Able To Access Edaravone?

At this time, edaravone is only approved for use in Japan, South Korea and the United States. Only citizens of these countries can access edaravone through the channels of their respective healthcare systems.

People with ALS/MND living outside these countries can, and have, attempted to access edaravone in Japan. A representative of the Japan ALS Association has provided a FAQ document that explains how international patients may access Radicut legally in Japan. This process can be challenging and expensive.

A purportedly similar compound with the brand name “Arone” is manufactured and distributed by Edinburgh Pharmaceuticals in India; this compound is unregulated. Neither Mitsubishi Tanabe nor MT Pharma America have any knowledge of its composition or manufacture. Anyone accessing this drug in India should proceed with caution, knowing that its safety and efficacy have not been tested. 

MT Pharma America said in a statement:

RADICAVA and Radicut are both manufactured only by Mitsubishi Tanabe Pharma Corporation in Japan in an FDA-approved facility. RADICAVA and Radicut undergo extensive quality control throughout the manufacturing and supply chain processes. We cannot comment on the quality, safety or efficacy of edaravone products manufactured by other companies in other facilities.

For more information and to access the best possible resources in your country, please contact your local ALS/MND association. Find contact information in our Directory.

News & Press Releases From Our Members In The US:

The ALS Association: Press Release

The ALS Association: FAQ About Radicava

ALS Therapy Development Institute

ALS Hope Foundation

Les Turner ALS Foundation

Other Resources:

Official FDA Announcement

Official MT Pharma America Press Release

Reuters News Story

This page and accompanying links will be updated if and when more information becomes available.