Reteplase Backed By FDA Panel

Boehringer Mannheim's recombinant plasminogen activator drug, reteplase (r-PA), has been recommended for approval by the US Food and Drug Administration's Cardiovascular and Renal Drugs Advisory Committee.

The panel unanimously agreed that reteplase should be approved for use "in the management of acute myocardial infarction for reduction of mortality, reduction of the incidence of congestive heart failure, improvement of ventricular function post-acute-MI, and lysis of thrombi obstructing coronary arteries."

The primary study filed in support of Boehringer's New Drug Application was the INJECT trial, reported in the Lancet last year (see also Marketletter August 14, 1995). This showed that reteplase was at least as effective as streptokinase in reducing mortality in AMI patients.