FDA Panel Backs Anti-Clot Drug
The Food and Drug Administration advisory panel on Friday backed a new drug to help prevent heart attacks.
Aggrastat, to be sold by Merck & Co., prevents blood platelets from clumping into dangerous clots that can block arteries. The panel said the drug could be used in combination with the blood thinner heparin in patients who come to emergency rooms with a form of chest pain known as unstable angina.
The FDA is not bound by advisory panel recommendations.
Unstable angina is the leading cause of U.S. hospital admissions and is usually treated with aspirin or heparin. Left untreated, clots can grow or break off, leading to a heart attack or death.
Drugs like Aggrastat are designed to delay or avoid the need for heart bypass surgery or artery-widening angioplasty procedures.
Researchers compared 773 patients taking the combination with 797 patients getting heparin alone. After a week, Aggrastat reduced the combined risk of death, heart attack and chest pain by 34%. About half these patients avoided angioplasty or bypass, whereas one-third had angioplasty and 23% had bypass.
The FDA panel declined to vote on backing Aggrastat’s use during angioplasty to prevent heart attacks, repeat surgeries and abrupt artery closure after reviewing results of a separate study.