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article imageFDA approves drug to treat ALS

By Tim Sandle     May 11, 2017 in Health
The U.S. Food and Drug Administration (FDA) has approved a drug called Radicava (generic name edaravone). The medication is designed to treat patients with amyotrophic lateral sclerosis.
Amyotrophic lateral sclerosis commonly referred to as ALS, motor neurone disease, or to Lou Gehrig's disease. The disease is rare and it acts to attack and destroy the nerve cells that control voluntary muscles. These muscles are an important part of everyday function: they control things like chewing, walking, breathing and talking. ALS is classified a few different ways: by how fast the disease progresses (slow or fast progressors), by whether it is inherited or sporadic, and by where it starts in the body.
The disease is progressive and slowly causes the muscles to weaken and it leads to paralysis. Most people with ALS eventually die from respiratory failure; this is usually within three to five years of the symptoms first appearing.
The new drug, which is marketed as Radicava (manufactured by Mitsubishi Tanabe Pharma America, Inc.), is administered intravenously by infusion. The treatment cycle begins with daily dosing for the course of 14 days. This is followed by a 14-day drug-free period. This phase then leads into treatment cycles that consist of dosing on 10 of the next 14 days, followed by 14 days drug-free, and then a repeat of the process.
The drug was tested during a six-month clinical trial, which took place in Japan. For the trial, 137 people took part. The subjects were divided up into two groups through a random selection process. Around half received edaravone and the other half were given a placebo. The results showed that, by week 24, the participants who received edaravone declined far less, based on a clinical assessment, compared to those who were administered the placebo.
Commenting on the drug launch, Dr. Eric Bastings, who is the deputy director of the Division of Neurology Products at the FDA's Center for Drug Evaluation and Research told American Pharmaceutical Review: "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.".
The medic added: "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." With this the FDA has granted Radicava orphan drug designation. This is a special regulation that gives incentives for pharmaceutical organizations to develop of drugs for the treatment of rare diseases.
More about Als, Drugs, amyotrophic lateral sclerosis, Fda
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