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ALS Breakthrough: FDA Approves New Drug For ALS Treatment

First Posted: May 08, 2017 04:00 AM EDT
FDA Approves Radicava To treat ALS (Lou Gehrig’s Disease)
FDA approves new drug known as Radicava or edaravone to treat amyotrophic lateral sclerosis or ALS.
(Photo : MedXclusive Learning/YouTube screenshot)

The U.S. Food and Drug Administration approved a new drug known as Radicava for ALS or amyotrophic lateral sclerosis treatment. It is the first new drug that has been approved by FDA for ALS treatment in 22 years.

Radicava, also referred to as edaravone, is the second drug in treating the said condition and is approved for use in the United States. The first drug for treating ALS is the riluzole that was approved in the United States in 1995, according to CNN.

The new drug is marketed by Mitsubishi Tanabe Pharma in the U.S. Edaravone is considered a nootropic and neuroprotective agent that sifts free radicals and protects against oxidative stress that is a factor in ALS onset and progression. This drug was approved in Japan for ALS treatment after having a four-year clinical trial.

Eric Bastings, MD, from the neurology products division in the agency's Center for Drug Evaluation and Research said that this is the first new treatment approved by the FDA for ALS in over two decades. They are pleased that people diagnosed with ALS will now have a supplementary option.

Meanwhile, Barbara Newhouse, president of the ALS Association, said that this is a significant time for people living with ALS. She further said that Radicava provides great promise for what they hope will be the first of many new treatments. She praised the work of MT Pharma America and the FDA, which are doing unprecedented steps to make this treatment reach the patients as quickly as possible.

Edaravone could slow down a functional decline in ALS patients by about one-third. In a six-month clinical trial in Japan that involved 137 participants, the patients who received edaravone declined less on a clinical evaluation of daily functioning in contrast to those patients who received a placebo.

MT Pharma estimated that Radicava would be available in August of this year. Its cost is about $1,086 per treatment, in which the drug is managed in cycles comprising 10 doses over 14 days and no dose for the next 14 days, according to ReliaWire.

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