FDA Reviews Azilect, NPF Participates in Hearing
Release date: 10/17/2011
An Advisory Committee to the Food and Drug Administration (FDA) voted against approving a submission by Teva Pharmaceuticals requesting permission to change the way that they describe the benefits of their drug Azilect (rasagiline). Azilect is currently approved to treat the symptoms of Parkinson’s disease; however Teva had requested approval to be able to also say that the drug, “slows clinical progression of Parkinson’s.”
What this means for patients
Dr. Michael Okun, NPF’s National Medical Director, says, “The FDA has met but not ruled as to whether they believe Azilect slows Parkinson's disease progression. Based on the vote of the advisory panel, it is unlikely FDA will approve the request. We will update the PD community as soon as there has been a ruling. I do not believe that the outcome of this hearing should change the immediate management of any PD patient, but if you are concerned we recommend you talk to your doctor.”
NPF joined with the other major PD organizations to issue a joint statement. The joint statement offers support for FDA’s evaluation of the science, and asks FDA to explain the criteria it will use in evaluating whether a drug or therapy slows Parkinson’s disease. We all hope that some of the studies going on right now will achieve that goal. In addition, Joyce Oberdorf, CEO of NPF, addressed how our Quality Improvement Initiative (QII) is helping us to understand the challenges we face in treating Parkinson’s.
NPF will update the Parkinson’s community with any developments.