On Tuesday, Oct 17, 2011 the FDA’s Peripheral and Central Nervous System Advisory Committee will discuss TEVA‘s NDA for AZILECT (rasagiline) for use in slowing the progression of Parkinson’s disease. AZILECT has been approved since 2006 for treating the signs and symptoms of Parkinson’s disease.
The FDA’s Briefing Document raises multiple regulatory issues which seem to support a negative view on approval by the FDA. These include study design, adherence to protocol (especially regarding the analyses) and interpretation of the results. The FDA conclusion seems to be “We don’t know if there is an adequate study that can be done. We don’t think the major study was designed to support the indication. The major study did not adhere to the planned statistical analyses. We think that the other study was even less well designed to support the indication. The results of both studies do not support the indication for disease modifying.”
I think the most interesting discussion will be around Dr. Paul Leber’s paper on the design of trials to study this indication.