Teva Pharmaceutical Industries Ltd. (Headquarters: Jerusalem, Israel, President: Israel Makov), which has a strategic alliance with Eisai Co., Ltd. (Headquarters: Tokyo, President: Haruo Naito), announced today that it submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the proposed Parkinson's disease treatment, rasagiline.
Once approved by the FDA, Teva Pharmaceutical Industries Ltd. and Eisai Co., Ltd. plan to co-promote rasagiline in the United States for Parkinson's disease via subsidiaries Teva Neuroscience, Inc. and Eisai Inc. Both companies have a strong presence in the field of neurology and are committed to educating health care professionals and patients with Parkinson's about advancements in treatment options and to providing patients with more choices for managing Parkinson's disease.
The submission is based on data collected in three Phase III clinical trials in early and advanced Parkinson's patients. Rasagiline is a novel, potent, second-generation irreversible monoamine oxidase type B (MAO-B) inhibitor.* It can be differentiated from earlier propargylamine MAO-B inhibitors by its chemical structure and greater potency, lack of amphetamine metabolites, and once-a-day dosing.
||MAO-B inhibitor * :
||MAO stands for monoamine oxidase, an enzyme which deactivates certain amine neurotransmitters through oxidation. MAO-B inhibitor selectively inhibits MAO-B that exists in corpus striatum in the brain and continuously inhibits the decomposition of dopamine, which results in increasing the level of dopamine in Parkinson's Disease.