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Executive Summary

BERLEX' BETAPACE ANTI-ARRHYTHMIC BETA BLOCKER APPROVED OCT. 30, more than four years after the NDA was originally submitted to FDA on June 30, 1988. The agency, however, only recently received the key data supporting approval: results from the National Heart, Lung & Blood Institute's ESVEM trial. FDA's Cardio-Renal Drugs Advisory Committee had conditioned its December 1990 approval recommendation for Betapace on the results of that trial. Betapace (sotalol) was designated by FDA as a "1-P" drug, indicating a new molecular entity given a priority review by the agency. Results from ESVEM (the Electrophysiology Study Versus Electrocardiographic Monitoring for Selection of Anti-arrhythmic Therapy of Ventricular Tachyarrhythmias) were presented at the American College of Cardiology meeting in April (" The Pink Sheet" April 20, p. 5). The ESVEM study evaluated six drugs for treatment of life-threatening ventricular arrhythmias: sotalol, Boehringer Ingelheim's Mexitil (mexilitene); Knoll's Rythmol (propafenone), quinidine gluconate, procainamide and Warner-Lambert's investigational drug Pimavar (pirmenol). After one year of treatment, the ESVEM trial showed that sotalol was the only drug that significantly reduced recurrence of arrhythmias. The sotalol recurrence rates were 21% compared to 44% for the other drugs in the study. Betapace also showed a reduction in all-cause mortality over six years compared to other treatments. The beta blocker originally was developed by Bristol-Myers Squibb for the orphan indication of treatment of life-threatening ventricular arrhythmias. BMS licensed sotalol to the German firm Schering AG and its U.S. subsidiary Berlex in November 1991. In return, Schering granted Bristol-Myers Squibb rights to Schering's gadolinium imaging agent patents (" The Pink Sheet" Dec. 2, 1991, T&G-1). Betapace is one of three recent FDA drug approvals, as the end-of-October period brought an approval rush for the second year in a row. During the week of Oct. 30, the agency also cleared Upjohn's Depo-Provera injection for contraception and Searle's once-a-day nonsteroidal anti-inflammatory drug Daypro (see following T&Gs).

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