Teva says Azilect slows progression of PD

22 June 2008

Israeli drug major Teva Pharmaceuticals Industries says that a Phase III study of Azilect (rasagiline) met its primary endpoints and showed that 1mg of the agent can slow down the progression of Parkinson's disease. In the ADAGIO trial, Azilect met all three primary endpoints, as well as the secondary and additional ones, all with statistical significance, the firm noted.

Teva intends to submit these results to regulatory authorities in the USA and Europe. According to the diversified generic drugmaker, the agent could become a breakthrough innovative medicine - the first PD treatment to receive a label for disease modification.

The design of the randomized, multicenter, double-blind, placebo-controlled, parallel-group study was based on the recommendations and guidance of the US Food and Drug Administration. The 18-month study, the first of its kind and one of the largest conducted in PD, involved 1,176 patients with early disease, in 14 countries and 129 medical centers. More detailed data analysis will take place over the coming weeks and will be presented to the medical community at a later date, noted the drugmaker.

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