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PDF Reports on Today's FDA Hearing on Rasagiline (Azilectģ)
- Oct 17 2011
The Peripheral and Central Nervous System Drugs Advisory Committee of the US Food and Drug Administration (FDA) has come to a conclusion — regarding a proposed label change for the Parkinson’s drug, rasagiline (Azilect®) — that the study sponsor has not provided substantial evidence of effectiveness for rasagiline as a treatment to delay clinical disease progression in patients with Parkinson’s disease.
As the Parkinson's Disease Foundation (PDF) reported earlier, the medication is currently on the market for the treatment of the signs and symptoms of Parkinson’s – both by itself, as initial therapy, and taken in conjunction with levodopa, as therapy in the later stages of disease progression. Teva Pharmaceutical Industries, Ltd., the company that manufactures rasagiline had asked the FDA to approve a change in label for the drug stating that the drug has been shown to “slow the clinical progression” of Parkinson’s.
Today’s hearing was designed to provide feedback from the public – including Parkinson’s organizations, people affected by Parkinson’s, scientists, doctors and others. This feedback included a statement from PDF and several other Parkinson’s organizations.
What Does it Mean?
This conclusion by the committee is not the final decision; it is a recommendation to the FDA based upon commentary from the public. This conclusion is one of many factors the FDA will use to make its decision.
People with Parkinson’s should note that this medication is currently on the market. No change will occur right now. If the FDA does not approve the label change, the medication will remain on the market.
PDF will update you as more information becomes available.
If you have further questions, please contact PDF’s National HelpLine, Monday through Friday from 9 AM to 5 PM ET at (800) 457-6676 or email@example.com.
Source Date: Oct 17 2011