Friday, Sep 14, 1984
South San Francisco, Calif. -- September 14, 1984 --On September 10-11, the Endocrinologic and Metabolic Drugs Advisory Committee to the U.S. Food and Drug Administration met in Bethesda, Maryland to review data on Genentech's Protropin (human growth hormone) produced through recombinant DNA technology. This meeting was part of a standard procedure used by the FDA to obtain input from scientific and medical experts regarding the results of clinical studies on an investigational product.
Safety and efficacy data were presented to the committee by Genentech and pediatric endocrinologists participating in human clinical evaluations of Proptropin. Other presentations were made by the FDA, experts in the medical field, and marketers of pituitary-derived human growth hormone.
The company believes the strength of the data has effectively addressed issues of product efficacy and safety. In its discussions, the committee indicated it agrees that Protropin increases the growth rate of children with hypopituitary dwarfism and appears to be safe based on the data seen to date. Nevertheless, the committee recommended that data on a somewhat larger number of patients be reviewed before marketing approval.
"Overall, we are pleased with the outcome of the meeting," said Robert A. Swanson, president and chief executive officer of Genentech. "We plan to work closely with the FDA in an effort to develop an approach that takes into account the committee's advice and enables us to obtain marketing approval with as little delay beyond this year as possible," said Swanson.
Genentech, Inc. is a leading biotechnology company, focusing on the development, manufacture and marketing of pharmaceuticals produced by recombinant DNA technology.
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