The Wall Street Journal -- April 13, 1998
Health:
FDA Advisory Panel
Recommends Approval
Of Merck Heart Drug
----
WASHINGTON -- A Food and Drug Administration
advisory panel overwhelmingly backed Merck & Co.'s
anti-clotting heart drug, Aggrastat, for acute coronary
syndrome.
In a 9-1 vote, FDA's cardiovascular and renal-drugs
advisory committee said the agency should approve the
drug for use with the standard care of heparin and aspirin.
Acute coronary syndrome includes unstable angina, which
is severe chest pain, and myocardial infarction, a blockage
in the heart so great its effects resemble a small heart
attack.
Christine Fanelle, a Merck spokeswoman, said because
Aggrastat has been designated for expedited review, a
final decision is expected by April 30.
The agency routinely consults outside advisory
committees when drugs come for approval. The
cardiovascular committee was set up for such a purpose.
The full FDA generally, but not always, follows the
recommendations of its expert panels.
Once Merck hears from the FDA, Ms. Fanelle said, the
company will rush the drug to market. Merck is eager to
tap into the market of more than one million people
yearly who are rushed to the hospital with severe chest
pains.
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