Teva Pharmaceutical Industries announced Monday that the FDA has expanded the indication for its Parkinson’s disease drug Azilect (rasagiline tablets), from monotherapy and adjunct to levodopa (LD) to now include adjunct to dopamine agonists (DAs).

The new indication means that Azilect can be used to treat all stages of Parkinson’s disease (PD), either alone or in combination with other PD medications, the Israel-based drugmaker said.

The FDA’s approval was based on a supplemental new drug application submitted by Teva, supported by clinical evidence from the ANDANTE study (Add oN to Dopamine AgoNists in the TrEatment of Parkinson's disease), the company noted.

Teva said study demonstrated that Azilect delivers a clinical benefit by greatly improving total Unified Parkinson's Disease Rating Scale (UPDRS) scores, while demonstrating tolerability. The drug was compared to placebo in patients on DA monotherapy.

"Azilect has been well studied and has been shown to be safe and effective as monotherapy in early PD and as an adjunct to LD in moderate-to-advanced PD. The ANDANTE study provides evidence that Azilect is also effective as an adjunct to dopamine agonist therapy," said Robert A. Hauser, professor of Neurology, Molecular Pharmacology and Physiology at the University of South Florida.

"The expanded AZILECT indication supports the concept of adding AZILECT to DA monotherapy to improve symptoms while offering another treatment option prior to either increasing the dose of DA monotherapy or initiating LD,” Hauser added. — Kellen Owings

Subscribe to Drug Industry Daily for complete coverage of the pharmaceutical industry. Click here for more information.