Teva Pharmaceutical Industries Ltd. (NYSE: TEVA; TASE: TEVA) and H. Lundbeck A/S announced today that a study of Azilect has met its primary endpoint in treating Parkinson's disease.
The double-blind, placebo controlled, randomized, multicenter study, known as ANDANTE (Add oN to Dopamine AgoNists in the TrEatment of Parkinson’s disease), assessed the efficacy and tolerability of Azilect as add-on treatment to dopamine agonists compared to placebo. While the efficacy of Azilect as adjunct to levodopa has been established in previous studies (leading to its indication as adjunct therapy to levodopa), its efficacy in combination with dopamine agonist monotherapy has not previously been studied. Results from the study demonstrated that the addition of 1 mg of Azilect daily provided a statistically significant improvement in total Unified Parkinson’s Disease Rating Scale from baseline to week 18 in patients sub-optimally controlled with dopamine agonist monotherapy compared to placebo. Azilect was well-tolerated with no significant difference in adverse events compared to placebo.
“The positive outcome of this study is important news for the PD community, for patients and physicians,” said University of South Florida, Director, Parkinson’s Disease & Movement Disorders Center Dr. Robert A. Hauser and primary investigator of the study. “In addition to rasagiline providing symptomatic benefit to patients sub-optimally controlled with dopamine agonist monotherapy, the study confirmed that rasagiline is well-tolerated and provided proof-of-concept for adding rasagiline to dopamine agonist therapy.”
Teva president of global R&D and chief scientific officer Dr. Michael Hayden said, “The ANDANTE data continue to clarify the clinical profile of Azilect and the role it plays in helping to meet the needs of those living with PD, at multiple points in the progression of their disease."
Published by Globes [online], Israel business news - www.globes-online.com - on March 20, 2013
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