Teva Receives FDA Approval For Parkinson's Drug Expanded Label
The U.S. Food and Drug Administration (FDA) has given its approval for Teva’s expanded indication for Azilect (rasagiline tablets). The FDA approved Azilect from being a monotherapy and adjunct to levodopa (LD) to now being an adjunct to dopamine agonists (DAs).
Azilect is indicated and approved as treatment for Parkinson’s disease (PD). The approval signifies that the drug is effective alone or in combination with other PD drugs, the company said. The new indication suggests that Azilect demonstrates efficacy across all stages of the disease.
Michael Hayden, president of global R&D and CSO at Teva Pharmaceutical, said, “The FDA approval of the expanded label for Azilect will be a welcome addition in the treatment of PD.” Hayden said that the company will continue research in areas of neurodegenerative disease, including Parkinson’s.
The approval was based on a supplemental new drug application (sNDA) submitted by Teva and supported by findings from the ANDANTE study (Add oN to Dopamine AgoNists in the TrEatment of Parkinson’s disease). ANDANTE showed that the drug significantly improved total Unified Parkinson’s Disease Rating Scale (UPDRS) scores compared to placebo in patients on DA monotherapy. The drug also demonstrated tolerability and safety in the study.
Robert Hauser, professor of neurology, molecular pharmacology, and physiology at the University of South Florida, said, “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. 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.”