Drug Companies Had Been Testing ReoPro for Treatment of Ischemic Strokes
On October 5, 2005 it was reported that Eli Lilly & Co. ("Lilly") and Johnson & Johnson ("J&J") have temporarily suspended a late-stage (Phase III) clinical trial involving their cardiac drug ReoPro due to some emerging safety concerns.
Based on the advice of an independent safety committee overseeing the ReoPro clinical trial, Lilly and J&J elected to stop giving ReoPro to patients already enrolled in the drug study. The purpose of this ReoPro study had been to test the cardiac drug for the treatment of acute ischemic strokes, the most common type of strokes, which are caused by the blockage of blood vessels.
It was reported by the Dow Jones Newswires that a spokesman for J&J's Centocor unit said the adverse events which raised safety concerns in the ReoPro study were intracranial hemorrhages and deaths. Insofar that the ReoPro clinical trial remains blinded, however, there is apparently no way for Lilly nor J&J to determine at this time whether the patients who suffered intracranial hemorrhages and deaths were taking ReoPro or a placebo used as part of the study.
In a press release, Jerome A. Boscia, senior vice president for clinical research at J&J's Centocor unit, stated:
Safety is our top priority, so we are halting enrollment in order for the SEMC [the independent safety committee] to carefully evaluate the data and determine whether the benefit-risk profile of ReoPro for the treatment of acute ischemic stroke warrants reinitiating trial enrollment.
ReoPro is known generically as abciximab. It is an intravenous drug that binds to blood platelets and inhibits clotting. ReoPro was first approved by the FDA in 1994 to be used along with noninvasive heart procedures to lower the risk of complications, and to treat chest pains before the procedures. In particular, ReoPro is suppose to help prevent blood clots in patients undergoing such coronary surgical procedures as angioplasty and stent insertion.
Lilly and J&J maintain that, despite halting the ReoPro study for safety reasons, there is no new data which indicates to the drug companies that the FDA will take any action to force them to change the package insert, or labeling, of ReoPro in order to warn about the possibilities of intracranial hemorrhage and death.
(Posted by: Tom Lamb)