Zeneca Seeks Post-MI Indication For Zestril

Zeneca Pharmaceuticals has submitted an application for approval to market its ACE inhibitor product Zestril (lisinopril) for an additional indication, the treatment of patients who have suffered a myocardial infarction, in major European markets.

According to the results of the 19,000-patient GISSI-3 study, early treatment with lisinopril (within 24 hours of a heart attack) decreases mortality and reduces the risk of further serious cardiovascular complications, including heart failure and left ventricular dysfunction. The preliminary results of GISSI-3 were announced towards the end of 1993 (Marketletter November 8, 1993).

Zestril is the third-largest selling ACE inhibitor in the world, achieving sales of L416 million ($651 million) in 1993, representing a rise of 41% over 1992. The drug had a 9% share of the plain and combination ACE inhibitor market in 1993, notes Zeneca. It is already approved for treating hypertension and heart failure in all major markets worldwide, with the exception of Japan where approval for CHF is expected sometime this year.