The FDA has formally accepted for review Centocor Inc.'s product andestablishment license applications (PLA and ELA) for the manufactureof CentoRx, a monoclonal antibody designed to prevent coronaryartery blockage caused by blood clots during and after high-riskcoronary angioplasty.The PLA addresses safety and efficacy of the product, while the ELAshows manufacturing capability. Centocor spokesman, Timothy Cost,told BioWorld he expects the data to go before a panel review meeting,the next three of which are in June, August and November.A six-month follow-up to the 2,100-patient Phase III trial demonstratedthat the use of CentoRx during angioplasty reduced by 23 percent thenumber of major ischemic events (including death, myocardialinfarction and revascularization). Clinicians already had determinedthat the drug was effective in the short term; it reduced by 36 percentthe ischemic events 30 days following treatment.Eli Lilly and Co. acquired the rights to CentoRx in July 1992 as part ofa $100 million infusion into Centocor, and in June 1993 exercised itsoption to be worldwide marketer and distributor of the drug. Cost saidLilly will be responsible for pricing, marketing and selling the drug.Centocor brought it through research and clinicals. The companies eachwill get 50 percent of the end product, he added.CentoRx is being tested in a 1,400-patient Phase III trial for unstableangina, which is expected to be completed by the end of the year. A2,100-patient Phase III trial for restenosis is scheduled to begin inApril.Jim Shrine
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