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news.Teva Pharmaceutical Industries has successfully completed Adagio, the Phase III study designed to demonstrate that Azilect 1mg tablets can slow down the progression of Parkinson's disease.
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In the trial, the currently marketed Azilect 1mg tablets met all three primary end points, as well as the secondary and additional end points, all with statistical significance. The study also confirmed the safety and tolerability of Azilect.
In addition, the 2mg dose in the study met two of the three primary end points as well as the secondary end point. The 2mg dose was also found to be safe and well tolerated.
The study protocol was based on the recommendations and guidance of the FDA. The 18-month study, the first of its kind, is one of the largest conducted in Parkinson’s disease, involving 1,176 patients with early Parkinson’s disease in 14 countries and 129 medical centers.
Teva intends to submit these results to the regulatory authorities in the US and Europe. Based on these results, Azilect could become the first Parkinson’s disease treatment to receive a label for disease modification.
Shlomo Yanai, president and CEO of Teva, said: “These positive results could dramatically increase the market potential for Azilect, allowing Azilect to join Copaxone as another major Teva drug for neurological disorders.”