FDA approves Radicava, first new ALS treatment in 20 years

By Eric DuVall

May 6 (UPI) -- The U.S. Food and Drug Administration on Friday approved the first new drug in decades to treat the fatal neurological disease ALS.

The FDA approved edaravone, sold under the drug name Radicava, produced by the drug company Mitsubishi Tanabe Pharma America. Clinical trials showed the drug slowed down the symptoms of ALS, also known as Lou Gehrig's Disease.


There is no known cure for ALS, a disease that slowly paralyzes people and is 100 percent fatal.

The FDA issued its approval after a Japanese clinical trial of a small pool of 137 ALS patients who were administered edaravone, declined less in terms of daily functioning compared to those who did not receive the drug.

Radicava is expected to be available in the United States by August.

FDA officials said they urged the Japanese drug company to apply to make the treatment available as quickly as possible.

"After learning about the use of edaravone to treat ALS in Japan, we rapidly engaged with the drug developer about filing a marketing application in the United States," said Dr. Eric Bastings, deputy director of the Division of Neurology Products at FDA.


The only other treatment available for ALS patients presently is the drug riluzole, sold under the brand name Rilutek. It was approved in 1996. That drug helps heal nerve cells attacked by the disease, but generally only extends a patient's life expectancy by a few months.

Edaravone works differently than riluzole. It interacts with the nerve-damaging compounds created as ALS progresses. It is administered intravenously daily for intervals of two weeks, followed by a two-week break over the course of a year.

The treatment is not without expense for health insurance companies. The cost per infusion is $1,000 and a full course of the medication comes in at more than $145,000. Its makers said it intends to work with patients whose health insurance plans that require significant copayments to lower the out-of-pocket cost.

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