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FDA Approves Expanded Label for Parkinson’s Drug Azilect (Rasagiline)
The new indication reflects the fact that rasagiline tablets can be used alone or in combination with other PD medications across all stages of the disease.
The FDA approval of the expanded label is based on a supplemental new drug application (sNDA), supported by data from the ANDANTE (Add ON to Dopamine AgoNists in the TrEatment of Parkinson’s Disease) trial. In that study, rasagiline provided a clinical benefit by significantly improving total Unified Parkinson’s Disease Rating Scale (UPDRS) scores compared with placebo in patients receiving DA monotherapy.
The ANDANTE trial was an 18-week, double-blind, placebo-controlled, randomized study assessing the safety and clinical benefit of rasagiline compared with placebo as add-on therapy to a stable dose of DAs in the treatment of early PD.
Results from the study demonstrated that the addition of rasagiline 1 mg/day provided a statistically significant improvement (primary endpoint: treatment effect –2.4 [P = 0.012]) in the total UPDRS score (parts I, II, and III; version three) from baseline to week 18 in patients suboptimally controlled with dopamine agonist monotherapy compared with placebo.
Moreover, data from the secondary endpoint analysis showed that the addition of rasagiline resulted in a statistically significant improvement in the UPDRS motor examination subscale (part III) (P = 0.007). There were no significant differences between treatment groups for the UPDRS activities of daily living (ADL) (P = 0.301) or Clinical Global Impression (CGI) scores.
The ANDANTE trial was conducted at 50 sites in the U.S. A total of 328 patients receiving sub-optimal DA monotherapy were randomly assigned to receive either add-on treatment with rasagiline (n = 163) or placebo (n = 165). The subjects returned to the clinic at 9 weeks for an interim visit and again at 18 weeks for an end-of-study visit.
To be enrolled, the subjects had to have received stable DA monotherapy for at least 30 days. In addition, they were unable to receive an optimal therapeutic dose of DAs because of intolerable side effects or were no longer experiencing sufficient control of their PD symptoms and required an additional therapeutic agent. Rescue treatment with levodopa was allowed once the subjects had completed 4 weeks of treatment with the study drug. DA therapy could not be adjusted during the study.
As a monoamine oxidase B (MAO-B) inhibitor, rasagiline acts by increasing available synaptic dopamine. This mechanism of action provided the rationale for add-on therapy to DAs in the management of PD.
Sources: Teva Pharmaceuticals; June 9, 2014; and Teva Pharmaceuticals; March 20, 2013.