Teva announced that the FDA has accepted its supplemental new drug indication application (sNDA) for Azilect (rasagiline) tablets, from monotherapy and adjunct to levodopa (LD) to now include adjunct to dopamine agonists (DAs). This approval allows Azilect to be used alone or in combination with other Parkinson’s disease medications.
The sNDA included data from the ANDANTE study (Add oN to Dopamine AgoNists in the TrEatment of Parkinson’s disease), which demonstrated that Azilect provides a clinical benefit by significantly improving total Unified Parkinson’s Disease Rating Scale (UPDRS) scores vs. placebo in patients on DA monotherapy, while also demonstrating tolerability.
Possible mechanisms of action of Azilect include its MAO-B inhibitory activity, which causes an increase in extracellular levels of dopamine in the striatum and subsequent increased dopaminergic activity that regulate rasagiline’s beneficial effects seen in models of dopaminergic motor dysfunction.
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