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.
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