FDA Accepts Expanded Label For Teva's Azilect In Parkinson's Disease

Teva Pharmaceutical Industries announced in a press release that the Food and Drug Administration (FDA) has approved a new indication for Azilect (rasagiline tablets). The medication for Parkinson’s disease (PD) was previously approved as a monotherapy or as an adjunct to levodopa (LD). The new label allows dopamine agonists (DAs) as an adjunct, giving physicians more flexibility in using the drug alone or with other medications. Teva states that the expanded label reinforces growing evidence that Azilect is effective in all stages of PD.

Robert A. Hauser, M.D., Professor at the University of South Florida and primary investigator of the studies supporting the label change, said, “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.”

FDA Action

The FDA approved the new indication based on Teva’s supplemental New Drug Application (sNDA). The application relied on data from the ANDANTE study (Add oN to Dopamine AgoNists in the TrEatment of Parkinson’s disease). Results from that study showed that, compared to placebo in patients on DA monotherapy, Azilect patients improved according to the Unified Parkinson’s Disease Rating Scale (UPDRS).

In the study at 58 sites with collaborator H. Lundbeck, Teva assessed the efficacy of rasagiline 1 mg as a first add-on treatment to dopamine agonist therapy in early PD patients. The study titled, “Double-blind, Placebo Controlled, Randomized, Multicenter Study to Assess the Safety and Clinical Benefit of Rasagiline as an Add on Therapy to Stable Dose of Dopamine Agonists in the Treatment of Early Parkinson's Disease,” was a randomized, double-blind, placebo-controlled trial. Its primary outcome measurement was a change from baseline to Week 18 in the UPDRS scale (Parts I, II, III, version 3).

Azilect

Azilect (rasagiline tablets) is indicated for the treatment of Parkinson’s disease (PD). It is currently approved for specific dosages and administrations. It is indicated as a monotherapy (1 mg once daily), as an adjunct to levodopa (0.5 mg once daily up to 1 mg daily as needed), and as an adjunct without levodopa (1 mg once daily). People taking ciprofloxacin or other CYP1A2 inhibitors take 0.5 mg once daily. People with mild hepatic impairment take 0.5 mg once daily.

In its press release announcing study results supporting the use of Azilect with dopamine agonists, Teva said that since Azilect is a monoamine oxidase B (MAO-B) inhibitor, it acts to increase synaptic dopamine, thereby providing the rationale for add-on therapy with dopamine agonists.