US approves Azilect for treatment of Parkinson's disease

The US Food and Drug Administration has approved Azilect (rasagiline) for the treatment of Parkinson's disease. Manufactured by Teva Pharmaceutical Industries in Tel Aviv, Israel, the drug is a monoamine oxidase type-B (MAO-B) inhibitor that blocks the breakdown of dopamine, a chemical that sends information to the parts of the brain that control movement and coordination.

"This is a welcome development for the more than 50,000 Americans who are, each year, diagnosed with Parkinson's disease," said Dr Steven Galson, director of the Center for Drug Evaluation and Research.

Azilect was approved for use as an initial single drug therapy in early Parkinson's disease, and as an addition to levodopa (a standard treatment for Parkinson's disease) in more advanced patients. The safety and effectiveness of Azilect was demonstrated in three 18- to 26-week controlled clinical trials.

This is the second product to come out of Teva's pipeline of products, which is derived largely from a close cooperation with Israeli universities and research institutes. It was approved in Europe and Israel in 2005, where it has been successfully launched.

Teva's US subsidiary, Teva Neuroscience, will promote Azilect in the US. Eisai Co, which has been involved in the development of rasagiline since May 2003, will continue to collaborate with Teva on the global co-development of rasagiline for potential use in the treatment of Alzheimer's disease. However, due to its own business considerations and priorities, Eisai is still considering whether or not to co-promote the drug. Azilect will become available in the US within 8 to 10 weeks.