Teva's Azilect meets all endpoints in ADAGIO trial

Israeli drug major Teva Pharmaceuticals Industries says that Azilect (rasagiline) reached all its endpoints in a late-stage trial. The Parkinson's disease drug demonstrated a significant improvement compared to those who started taking it nine months later, according to data from the Phase III ADAGIO trial, which were presented at the 12th Congress of European Federation of Neurological Societies, held in Madrid, Spain.

The 1mg dose met all three primary endpoints, as well as the secondary endpoint, with statistical significance. The primary analysis included three hierarchical endpoints based on Total-Unified Parkinson's Disease Rating Scale scores: A) superiority of slopes in weeks 12-36 (-0.05; p=0.013); change from baseline to week 72 (p=0.025); and non-inferiority of slopes (0.15 margin) in weeks 48-72. The safety profile of Azilect seen in the ADAGIO study was similar to previous experience with the agent, Teva noted.