Biosimilar drugs

FDA Approves First New ALS Drug in More than 20 Years

The Food and Drug Administration has approved the drug Radicava, also known as edaravone, for the treatment for amyotrophic lateral sclerosis (ALS).  This is the first time an ALS drug has been cleared for use in the U.S. since the drug riluzole was approved in 1995.
The Centers for Disease Control and Prevention estimates between 12,000 and 15,000 people in the U.S. are living with ALS, commonly referred to as Lou Gehrig’s disease.  The fatal disease affects nerve cells, which gradually breakdown and die, causing muscle weakness and impairment of voluntary muscle movements, leading to paralysis.  There is no known cure and most patients with ALS usually die from respiratory failure within three to five years from when symptoms first appear.
Interestingly the new drug, developed by Mitsubishi Tanabe Parma, was approved solely based on compelling data from a six-month trial conducted in Japan in 2015.
“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,” Eric Bastings, M.D., deputy director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research, said in a statement. “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.”
Results from that phase 3, placebo-controlled study of 137 participants showed that the drug provided a 33 percent reduction in physical decline in ALS patients, compared to those treated with a placebo.  The ALS drug can’t reverse or cure ALS, but it can delay the disease’s progression.
Radicava is an intravenous infusion that is initially administered daily for 14 days, followed by a 14-day drug-free period. Successive treatments entail dosing on 10 out of 14 days, followed by 14 drug-free days. Each infusion is estimated to cost about $1,000.
The most common adverse side effects from the drug were bruising, problems walking, and headache.
The FDA also granted Radicava Orphan Drug Designation.  The company anticipates the treatment will be available in the U.S. by August of this year.

Date: 5/16/2017

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