FDA approves expanded label for Azilect


The US Food and Drug Administration (FDA) has expanded the indication for Azilect (rasagiline tablets) from monotherapy and adjunct to levodopa to now include adjunct to dopamine agonists. The new indication reflects that Azilect can be used alone or in combination with other Parkinson’s disease medications.

“The FDA approval of the expanded label for Azilect will be a welcome addition in the treatment of Parkinson’s disease,” says Michael Hayden, president of Global Research & Development and chief scientific officer at Teva Pharmaceutical Industries. “Teva continues its commitment to those living with Parkinson’s disease and to research in areas of neurodegenerative diseases to develop solutions for patients with unmet needs.”

The FDA approval of the expanded label is based on a supplemental new drug application submitted by Teva, supported by data from the ANDANTE study (Add on to dopamine agonists in the treatment of Parkinson’s disease).The study demonstrated Azilect provides a clinical benefit by significantly improving total Unified Parkinson’s Disease Rating Scale (UPDRS) scores compared to placebo in patients on dopamine agonists monotherapy, while demonstrating tolerability.

“Azilect has been well studied and has been shown to be safe and effective as monotherapy in early Parkinson’s disease and as an adjunct to levodopa in moderate-to-advanced Parkinson’s disease. The ANDANTE study provides evidence that Azilect is also effective as an adjunct to dopamine agonist therapy,” says Robert A Hauser, professor of neurology, molecular pharmacology, and physiology at the University of South Florida, USA. “The expanded Azilect indication supports the concept of adding Azilect to dopamine agonist monotherapy to improve symptoms while offering another treatment option prior to either increasing the dose of dopamine agonist monotherapy or initiating levodopa.”