Cor Therapeutics has decided to go ahead and file a New Drug Application for Integrelin, its glycoprotein IIb/IIIa receptor antagonist, and forecasts that this will be sometime in the first quarter of 1996. The application will be based on the results of the IMPACT II study, which were presented at the European Society of Cardiology meeting in 1995.
IMPACT II provided mixed results - the drug demonstrated a significant effect on the primary composite endpoint of all-cause mortality, myocardial infarction or the need for revascularization/stent placement at 24 hours, but appeared to have no preventive effects on the rate of restenosis, as was seen in the EPIC trial of Centocor's ReoPro (abciximab; Marketletter September 11, 1995). Schering-Plough is Cor's worldwide development partner for Integrelin.
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