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news.Teva Pharmaceutical Industries and H Lundbeck have been issued a marketing authorization, valid throughout the European Union, for Azilect for the treatment of Parkinson's disease.
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The European approval covers the use of Azilect (known in the US as Agilect) both as monotherapy in patients with early Parkinson’s disease (PD) and as adjunct treatment in moderate to advanced disease. The companies intend to market the product in various countries across Europe during the second quarter of 2005.
Approval for Azilect was based on data from three large, multicenter clinical studies. These studies in over 1,600 patients demonstrated that Azilect given once daily was effective, safe and well-tolerated, whether given on its own in the early stages of PD or added to existing therapy in more advanced disease.
Patients with moderate-to-advanced PD experienced significant improvements in ‘on-off’ fluctuations and motor function when Azilect was added to levodopa and other PD medications.
The development of Azilect is part of a long-term strategic alliance for co-development in PD and European marketing between Lundbeck and Teva, and Azilect is a joint development of Teva and the Technion – Israel Institute of Technology.