US FDA clears Teva's Azilect for early PD

Israeli drugmaker Teva Pharmaceutical Industries says that the US Food and Drug Administration has approved its oral drug Azilect (rasagiline), the first once-daily tablet for Parkinson's disease, for use as initial monotherapy in early PD and as adjunct therapy to levodopa in moderate-to-advanced disease.

The drug, which is expected to become available later this year in two dosage strengths, was approved on the basis of data from three multicenter, multinational, double-blind, randomized, placebo-controlled, clinical studies involving more than 1,500 patients. According to the firm, these provided statistically-significant evidence of efficacy, while also demonstrating good tolerability.

One of these evaluations, known as the TEMPO trial, showed early-stage PD patients on Azilect monotherapy had better symptom control as measured by total Unified Parkinson Disease Rating Scale over a 26-week period versus placebo. Also, the PRESTO study demonstrated a significant incremental benefit when the Teva drug was added to levodopa treatment and other concomitant PD drugs. In this trial, the amount of off time, the period where levodopa wears off, was significantly reduced and motor symptoms were improved compared to placebo.