Actelion/Genentech tezosentan
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Companies expect to file an NDA in the fourth quarter for the intravenous dual endothelin receptor antagonist for treatment of acute heart failure. Results from RITZ 2 (Randomized Intravenous TeZosentan), one of two pivotal studies, will be presented March 20 at the American College of Cardiology meeting. The study randomized 292 patients with acute decompensated heart failure to either tezosentan 50 mg/hour or 100 mg/hour or placebo for 24 hours. Investigators reported that "both doses of tezosentan significantly improved [cardiac index] and [pulmonary capillary wedge pressure] at 6 hours vs. placebo," and "the effect was maintained for the whole 24 hours of treatment and for at least 6 hours after stopping treatment
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