Wednesday, Oct 4, 1995
South San Francisco, Calif. -- October 4, 1995 --Genentech, Inc. (NYSE:GNE) today announced that it has submitted to the U.S. Food and Drug Administration a New Drug Application (NDA) for approval to market Nutropin® (somatropin [rDNA origin] for injection) human growth hormone for the treatment of growth failure associated with Turner syndrome.
The NDA submission is supported by two long-term, multi-center clinical studies sponsored by Genentech, which incorporate a 12-year research effort. The results of these clinical trials show improvement in the growth rate and overall increase in the adult height of girls with Turner syndrome treated with Nutropin, compared to their predicted adult height prior to beginning treatment or matched untreated historical control patients.
Turner syndrome is a genetic disorder in females caused when all or part of one of the X chromosomes is lost before or near the time of conception. The disorder results in various medical problems, including short stature: the average height of an untreated adult woman with Turner syndrome is 4 feet 8 inches. In addition to growth failure, other features and symptoms of Turner syndrome include lack of sexual development, arms that turn out slightly at the elbow, webbing of the neck, and a low hairline in the back. About 4,000 girls in the U.S. who suffer from short stature associated with this disorder may be eligible for Nutropin therapy.
"This NDA submission represents a diligent research and development effort in providing the clinical data necessary to demonstrate efficacy in a severely affected patient population," said Barry M. Sherman, M.D., Genentech's senior vice president and chief medical officer. "We are optimistic that as a result of the persistence of our researchers, the study participants, and their physicians, Turner patients and their families can look forward to the general availability of an important treatment."
Genentech currently markets two human growth hormone products in the U.S. and Canada: Protropin® (somatrem for injection) and Nutropin for growth hormone inadequacy in children, and Nutropin for children with growth failure due to chronic renal insufficiency.
Genentech, Inc. is a leading biotechnology company that discovers, develops, manufactures, and markets human pharmaceuticals for significant unmet medical needs. The Company has headquarters in South San Francisco and is traded on the New York and Pacific stock exchanges under the symbol GNE.
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