Teva : FDA Oks Expanded Label For Azilect For Treatment Across All Stages Of PD

(RTTNews) - Teva Pharmaceutical Industries Ltd. (TEVA) announced Monday that the U.S. Food and Drug Administration or FDA has expanded the indication for AZILECT (rasagiline tablets) from monotherapy and adjunct to levodopa or LD to now include adjunct to dopamine agonists or DAs.

The new indication reflects that Azilect can be used alone or in combination with other Parkinson's disease or PD medications. The approval reinforces the growing clinical evidence demonstrating the benefit of Azilect across all stages of PD.

The FDA approval of the expanded label is based on a supplemental new drug application or sNDA 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 DA monotherapy, while demonstrating tolerability.