Teva wins expanded indication for Parkinson's drug
- FDA has approved Teva’s Azilect for all stages of Parkinson’s disease.
- The approval of the expanded indication is based on positive data from a study.
- Azilect can be used as monotherapy or in conjunction with levodopa, and now it can also be used in conjunction with dopamine agonists (DAs).
Teva submitted a supplemental NDA based on the strength of the study data, which evaluated the efficacy and safety of adding Azilect to DA treatment in patients who were being treated with DA monotherapy, but were not well controlled. In an 18-week, randomized, placebo-controlled trial, which evaluated 165 Azilect/DA patients and 163 placebo patients, there was a significant improvement in Unified Parkinson’s Disease Rating Scale (UPDRS) scores in the area involving motor skills in the combo group. However, there was no significant difference in activities of daily living (ADL) scores between the two groups.
Azilect, a monoamine oxidase inhibitor, can significantly decrease some of the symptoms associated with PD, but it is not a disease-modifying drug. In 2011, Teva attempted to gain approval for Azilect as a therapy that can slow down the underlying disease process in patients with PD, but FDA found the evidence inconsistent. This year’s approval will increase the role of Azilect as a go-to treatment agent either as monotherapy or adjunctive therapy with two standard-of-care treatments.
- Pharmaceutical Business Review Teva's Azilect gets FDA approval to treat all stages of Parkinson's disease