FDA Approved Drug to Treat ALS

The Food and Drug Administration (FDA) has approved a drug called Radicava (edaravone) to treat patients with ALS. It is the first new treatment for ALS that has been approved in more than two decades.

ALS stands for amyotrophic lateral sclerosis. It is commonly referred to as Lou Gehrig’s disease after the famous baseball player who was diagnosed with it. Awareness of ALS rose during the popular ice bucket challenge that went viral in the summer of 2014.

ALS is a progressive neurodegenerative disease that affects nerve cells in the brain and the spinal cord. People who have ALS lose the ability to initiate and control muscle movement, which often leads to total paralysis and death within two to five years of diagnosis.

Radicava is an intravenous infusion given by a health care professional. It is administered with an initial treatment cycle of daily dosing for 14 days, followed by a 14-day drug-free period. Subsequent treatment cycles consist of dosing on 10 of 14 days, followed by 14 days drug-free.

The chemical name of Radicava is edaravone. It has been used for treatment of ALS in Japan. The efficacy of edravone was demonstrated in a six-month trial conducted in Japan. There are some serious risks that come with Radicava, including hives, swelling, or shortness of breath, and allergic reactions to sodium bisulfite (an ingredient in the drug). The most common adverse reactions were bruising and gait disturbance.

The FDA was expected to make its decision on edaravone by June 16, 2017. The drug is to be sold under the brand name Radicava in the United States. It should be available in the United States by August.

According to Mitisubishi Tanabe Pharma, makers of Radicava (edravone), Radicava would cost $1,086 per infusion. If taken for 12 months or 13 cycles, according to the dosing and administration per the label, the cost before government discount would be $145,524.

Most of the time, ALS is not inherited. However, if there is more than one person in your family who has ALS and/or frontotemporal dementia, or if someone was diagnosed at a younger age (such as age 45), you might want to meet with a genetic counselor. A genetic counselor can help you work through the pros and cons of genetic testing. Genetic counseling does not always lead to genetic testing.

Related Articles at FamilyTree.com:

* Ice Bucket Challenge Leads to New Discovery

* August is for Raising Awareness of ALS

* FDA Allows 23andMe to Sell Genetic Tests for Disease Risk to Consumers

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