Teva rasagiline submission
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Teva submits rasagiline NDA Aug. 8 for treatment of Parkinson's disease (PD). Rasagiline differs from other MAO-B inhibitors "in its chemical structure, its greater potency, lack of amphetamine metabolites and once-a-day dosing," the firm says. Somerset's Eldepryl (selegiline), the only approved PD drug in the MAO-B class, is administered twice daily. Teva will likely stress efficacy in the "off" period when PD symptoms are not adequately controlled. In the 18-week LARGO trial, rasagiline added to levodopa reduced "off" time by 1.2 hours daily or 21%. Rasagiline also significantly improved motor function based on the Unified PD Rating Scale in "on" and "off" states, while the comparator, Novartis' Comtan (entacapone), similarly improved scores in the "on" state but did not impact scores in the "off" state. Teva recently signed a co-promotion deal with Eisai; the firms are also developing the agent for Alzheimer's disease (1Pharmaceutical Approvals Monthly June 1, 2003, In Brief)...