FDA rejects ADAGIO study results as showing Azilect delays progression of Parkinsons Disease

The FDA Peripheral and Central Nervous System Drugs Advisory Committee decided that the 1,176 patient, randomized, multicentre, double-blind study, known as ADAGIO, failed to provide compelling evidence that the 1mg dose of Azilect(rasagiline mesylate)from Teva met its specified criteria in delaying the progression of Parkinsons Disease. The data were seen as promising but not compelling. Azilect was approved in 2006 in the USA and in 2005 in the EU as a treatment for the signs and symptoms of idiopathic Parkinson's disease, as monotherapy and as adjunctive therapy to levodopa. Teva hoped to expand the indication to slowing clinical progression of the disease but this trial did not convince the FDA. American regulators have never approved a treatment for disease modification in any neurodegenerative condition.