Cor regulatory update

CORR submitted an NDA for its Integrilin GPIIb/IIIa inhibitor of platelets to prevent acute cardiac ischemic complications in all patients undergoing angioplasty. The submission includes both 30-day and six month data on the effects of the drug. According to the company, the absolute reduction in event rates seen at 30 days - primarily in death and myocardial infarction - was maintained at six months.

In the Phase III study, the event rate of death and MI was 2.5 percent in the placebo group, 1.3 percent in the low dose group (135 µg/kg bolus followed by 0.5 µg/kg/min infusion) and 2.0 percent in the high dose group (135 µg/kg bolus followed by 0.75 µg/kg/min infusion). Those positive trends didn't reach statistical significance (see BioCentury Extra June 15, 1995). ...