The U.S. Food and Drug Administration (FDA) just approved the first new drug to treat amyotrophic lateral sclerosis (A.L.S.). Many may remember the devastating neurological disease from social media’s viral “Ice Bucket Challenge” a few years ago that was organized to raise funds to raise awareness and funds to battle the illness. The drug, called Radicava, is the first new treatment developed for ALS in more than 20 years, The New York Times reports.
A.L.S. is also known as Lou Gehrig’s disease, a progressive, always fatal condition that destroys nerve cells that control voluntary muscles throughout the body, including those used to eat, walk, breathe and talk. A.L.S. experts say most patients die from respiratory failure within three to five years after their symptoms begin, and that up to 15,000 Americans currently suffer from the condition. Until now, the FDA only approved one drug — riluzole — to treat A.L.S. in the United States.
This new drug, Radicava (edaravone) is taken intravenously daily for 14 days, followed by 14 days without the drug. Subsequent treatment cycles consist of IV treatment for 10 out of 14 days, followed by two weeks without the treatment. Recent studies show the drug helps to slow the progression of the illness but doesn’t cure ALS or make patients feel better or stronger.
The FDA’s based it’s approval of the med on a six-month clinical trial conducted in Japan that included 137 patients with ALS who received either the full course of treatment or an inactive placebo for 24 weeks. Though effects were modest, researchers found that patients taking the drug suffered significantly less loss of physical function than those taking the placebo.
Common side effects of Radicava included bruising and problems walking. In addition, scientists noted more serious risks, such as hives, swelling or shortness of breath and allergic reactions to sodium bisulfite, an ingredient in the drug.
“I’m very happy, frankly, that there is a second drug approved for A.L.S.,” said Neil Schneider, MD, PhD, director of the Eleanor and Lou Gehrig ALS Center at Columbia Medical Center. However, the doctor also said he wasn’t sure if he’d recommend it to all of his patients. “If it were a pill and easily administered, I’d be less reluctant to use it,” Schneider added.
Radicava also has a steep price tag. According to researchers, receiving regular doses of the drug could cost as much as $145,524 a year. Still, experts said the new treatment does provide a much-needed second alternative to treating those who suffer from the disease.
Click here to learn more about Parkinson’s disease, another progressive neurological illness.