Parkinson’s Drug Receives FDA Approval
There’s a new tool in the fight against Parkinson’s disease. The FDA today granted approval for Azilect® (Rasagiline), a drug developed by Technion-Israel Institute of Technology researchers. The drug will be available in the United States within 8 to 10 weeks, and marketed by Teva Pharmaceutical Industries, Ltd.
The brainchild of Technion Professors Moussa Youdim and John Finberg, Azilect is the first once-daily product for the treatment of Parkinson’s, a chronic, degenerative disease affecting a million people in the United States (4 million around the world).
Azilect is one of the few treatment options in the U.S. for all stages of Parkinson’s, including use as a stand-alone early-stage therapy and in combination with levodopa (a standard treatment for Parkinson’s disease) in more advanced stages of the disease. The drug is a monoamine oxidase type-B (MAO-B) inhibitor that blocks the breakdown of dopamine, a chemical that sends information to the parts of the brain that control movement and coordination.
"The approval of Azilect by the FDA represents important news for people with Parkinson’s disease,” said Dr. Warren Olanow, professor and chairman of the Department of Neurology at Mount Sinai School of Medicine. “Patients can now look forward to an effective new treatment option that improves symptoms and offers the simplicity of once-daily dosing without titration (careful measuring of dosage).”
FDA approval is based on data from three large, multicenter, multinational, double-blind, randomized, placebo-controlled clinical studies of more than 1,600 patients.
Teva has begun a large clinical study to investigate the drug’s effect on slowing the progression of Parkinson’s disease.
American Technion Society
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