To: Anthony Wong who wrote (141 ) 4/8/1998 6:23:00 PM From: Anthony Wong Read Replies (1) | Respond to of 641
DOW JONES ONLINE NEWS FDA PANEL WILL REVIEW MERCK'S HEART DRUG AGGRASTAT FRIDAY April 08, 1998 2:53 PM WASHINGTON -(Dow Jones)- A Food and Drug Administration advisory panel will review Merck & Co.'s marketing application for its investigational heart drug Aggrastat on Friday. If approved, the drug will enter a crowded marketplace and compete with Centocor Corp.'s (CNTO) and Eli Lilly & Co.'s (LLY) ReoPro, which is widely used, and Cor Therapeutics Inc.'s (CORR) Integrilin, which the FDA indicated it will soon appprove. Still, some analysts predict that peak sales of Aggrastat could reach $550 million by 2001. Specifically, Merck is seeking FDA approval of Aggrastat in combination with the widely used blood-thinning drug heparin for the treatment of patients with unstable angina or so-called non-Q-wave heart attack to prevent further cardiac damage. It is also seeking approval to use the drug in patients undergoing angioplasties. Aggrastat belongs to a class of drugs referred to as "super aspirins" or "platelet blockers" because they inhibit the formation of blood clots around damaged tissue. Experts say that clots often form when cholesterol deposits tear the cells that line blood vessels. Two previously released studies showed Aggrastat, when used in combination with heparin, helped prevent heart attacks. One study, presented last August at a meeting of the Congress of the European Society of Cardiology, compared 797 patients who were given heparin with another group of 773 individuals who were given both heparin and Aggrastat. The study showed that after six months, 8.3% of the patients getting the combined dosage suffered heart attacks, compared with 10.5% of those getting only heparin. Another study, released in March 1997, showed Aggrastat reduced deaths by 40% compared to patients who were treated only with heparin. That study enrolled over 3,200 patients. Individuals suffering from angina experience chest pain caused by lack of oxygen to the heart muscle, usually a result of poor blood supply. Medical experts indicate that roughly 1.2 million individuals are hospitalized annually for the treatment of the disorder. Patients are typically admitted to a coronary-care unit and given aspirin and heparin. The Wall Street Journal reported last week that the consensus among analysts is that Aggrastat will be approved by the FDA. However, some analysts indicated that Merck's clinical trials of Aggrastat showed limited effectiveness in treating angioplasty patients. Copyright (c) 1998 Dow Jones & Company, Inc. All Rights Reserved.