The U.S. Food and Drug Administration has approved a new drug Friday to treat patients suffering from amyotrophic latersclerosis (ALS) or commonly known as Lou Gehrig's disease.
The drug, Radicava, is the first new treatment approved specifically for ALS in 22 years.
"This is the first new treatment approved by the FDA for ALS in many years, and we are pleased that people with ALS will now have an additional option" said Eric Bastings, M.D., deputy director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research.
The drug is "an intravenous infusion given by a health care professional," with "an initial treatment cycle of daily dosing for 14 days, followed by a 14-day drug-free period," the FDA said in a news release.
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ALS is a progressive neurodegenerative disease that affects nerve cells in the brain and the spinal cord. Eventually, people with 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. For unknown reasons, veterans are twice as likely to develop ALS as the general population.
The ALS Association, the only national nonprofit fighting ALS on every front, applauded FDA's fast decision in approving the drug.
The FDA approved Radicava less than a year after Mitsubishi Tanabe Pharma Corporation submitted a New Drug Application. The only other approved treatment specifically for ALS, riluzole, was approved in 1995.
"We thank the FDA and MT Pharma for working together to expedite the approval of the first new ALS-specific treatment in decades," said Barbara Newhouse, president and CEO of The ALS Association.
More information about Radicava, including Frequently Asked Questions, can be found at www.alsa.org/radicava.