Panel Says No to Progression Claim for Rasagiline

The panel agreed, cited other issues with the data, and voted unanimously that the study did not provide compelling evidence that the 1-mg, once-daily dose was effective. While they agreed that there was an unmet need for a treatment that slowed progression and that the data were promising and showed a signal for a disease-modifying effect, they said the evidence did not meet the high bar that should be set for proving such an effect, considering the enormous public health implications of a neuroprotection claim for a Parkinson's disease treatment.

The FDA usually follows the recommendations of its advisory panels. Panelists have been cleared of potential conflicts of interest related to the topic of the meeting. Occasionally, a panelist may be given a waiver, but not at this meeting.

In addition to Teva, the companies on Dr. Olanow's conflict of interest disclosure statement included Ceregene, Novartis, Lundbeck, and Merck Serono.