WASHINGTON, Nov. 12, “Reuter: The US. Food and Drug Administration (FDA) plans to announced approval of a new anti-heart-attack drug at a news conference on Friday, agency sources said.
“Food and Drug Commissioner Frank E. Young will provide information on an emergency treatment that will have an impact on the 1.25 million Americans who have heart attacks each year”, the agency said. The FDA declined to go beyond that statement but agency sources said the Friday morning news conference had been called California based Genentech Inc. hopes to market.
A Gene tech official contacted at the company’s San Francisco headquarters declined comment.
TPA, or tissue plasminogen activator, is a bioengineered blood clot dissolving agent. Industry analysis estimate it could provide up to one billion dollars a year in sales ‘once on the market.
“The compound has been found in tests on humans to prevent heart attacks and even stop those in progress by clearing blockages in the veins and arteries that bring blood to the heart.
But in a surprise setback last May, an FDA Committee of outside medical experts voted against recommending final marketing approval for the drug, The vote created an uproar in the medical ‘community and sent Genentech stock plummeting.
Commissioner Young ordered a special review, but approval was still widely expected.
TPA is found naturally in human blood and is part of the body’s own natural mechanism for preventing blood clotting.
It is present in blood in levels that are too low to be profitably extracted for use as a drug, but Genentech produces the substance in living cells that have been genetically altered to produce TPA in commercial quantities.
Article extracted from this publication >> November 20, 1987
