Centocor Inc. announced late Wednesday that it has submitteda product license application (PLA) to the FDA for approval tomarket CentoRx for preventing coronary artery blockagecaused by blood clots in patients who have undergone high-risk angioplasty.
At the same time, Centocor (NASDAQ:CNTO) of Malvern, Pa.,filed a new drug submission with the Health Protection Branchin Canada for approval to market CentoRx. Centocor said that itplans to apply for approval of the product in Europe in the firstquarter of 1994.
CentoRx, or 7E3, is a humanized monoclonal antibody fragmentdesigned to bind to surface receptors on blood platelets (theGPIIb/IIIa receptor), thus preventing the aggregation andclotting that can lead to blood vessel closure. The results of themulticenter, 2,100-patient EPIC trial (Evaluation of IIb/IIIaPlatelet Receptor Antagonist 7E3 in Preventing IschemicComplications) were reported in March at the American Collegeof Cardiology Meeting in Anaheim, Calif. Those datademonstrated that CentoRx can reduce by 36 percent theoccurrence of heart attack and the need for emergency repeatangioplasty in patients with coronary artery disease at highrisk for complications following balloon angioplasty.
And the six-month follow-up data from the EPIC trial, whichwere presented in November at the annual meeting of theAmerican Heart Association in Atlanta, supported the long-term ability of CentoRx to reduce the risk of blood clotting afterballoon angioplasty. The data demonstrated that use of themonoclonal antibody-based drug during angioplasty was ableto reduce by 23 percent the number of major ischemic eventsoccurring in these 2,100 patients six months after they hadbeen treated.
Centocor is also conducting clinical trials on the ability ofCentoRx to treat angina. The Phase III trials were initiated inJune.
Eli Lilly and Co. acquired the rights to CentoRx in July 1992 aspart of its $100 million infusion into Centocor, and in late Juneexercised its option to be the worldwide marketer anddistributor of the heart drug.
Centocor's stock lost 13 cents a share on Wednesday, closing at$11.63.
-- Jennifer Van Brunt Senior Editor
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