Israel’s Teva Pharmaceutical Industries and Danish partner, Lundbeck, are celebrating after winning European approval for Azilect (rasagiline) in the treatment of Parkinson’s disease both as monotherapy in patients with early disease, and as PD and as adjunct treatment in moderate-to-advanced disease. The companies reiterated that they hope to launch the product, which is also cleared in Israel [[05/01/05g]], in the second quarter of 2005 [[19/11/04f]].
Approval was based on data from three large clinical trials, which included over 1,600 patients in all stages of disease. In early PD, Azilect monotherapy showed significant improvement in motor symptoms and quality of life. In advanced PD, it significantly improved the disabling motor fluctuations associated with advanced stages of the disease. It also differs from earlier drugs in its class, offering greater potency and the potential for once-a-day dosing [[10/09/03d]].
PD is a chronic, progressive neurodegenerative condition, the exact cause of which is not known. As the disease progresses, symptoms such as tremor, slowness of movement, and stiffness, worsen and eventually impair the patient’s ability to function. Men and women are affected equally, with around four million people around the world suffering from the condition, including in excess of one million people within the European Union. In 2003, Lundbeck and Teva estimate sales of PD drugs topped $2.2 billion dollars – around 40% of which was in Europe.