Wednesday, Apr 1, 1987
FDA Cardiorenal Advisory Committee to Review t-PA
South San Francisco, Calif. -- April 1, 1987 -- The company submitted an application to the FDA for approval to market
Activase for the treatment of life threatening blood clots that cause heart
attacks in April 1986. The manufacturing process for Activase was reviewed by an
advisory committee last fall. This upcoming review will discuss t-PA and other
thrombolytic agents in myocardial infarctions. The cardiorenal advisory
committee is comprised of experts in the field of cardiology, physicians and
researchers, who act as consultants to the FDA.
Activase is a human protein found in minute quantities in the blood
system. It has been under clinical investigation as a thrombolytic agent to
dissolve blood clots in heart attack victims since early 1984. To date, more
than 4,000 have been treated with Activase in clinical trials worldwide.
Genentech is a leading biotechnology company, focusing on the
development, manufacture and marketing of pharmaceuticals produced by
recombinant DNA technology.
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