Tuesday, Dec 10, 1996
South San Francisco, Calif. -- December 10, 1996 --Genentech, Inc., (NYSE: GNE) today announced that Nutropin® [somatropin (rDNA origin) for injection] human growth hormone for the treatment of growth failure associated with Turner syndrome was recommended by a vote of 6-1 for marketing clearance by the Endocrinologic and Metabolic Drug Advisory Committee to the U.S. Food and Drug Administration (FDA). This recommendation was based on data presented from four clinical trials conducted by Genentech and Eli Lilly & Co. FDA clearance of this use would be the first U.S.-approved treatment for short stature associated with Turner syndrome.
Turner syndrome affects approximately one in 2,500 female, live births.
Turner syndrome is a chromosomal disorder that affects females exclusively and is characterized, in part, by short stature and ovarian dysfunction. It is caused by the absence of all or part of one of the X chromosomes.
"We are extremely pleased with the Advisory Committee's recommendation to approve Nutropin for Turner syndrome," said Kenneth Attie, M.D., clinical scientist, Genentech. "This recommendation is based on more than 12 years of research at Genentech, which demonstrates our commitment to Turner syndrome patients and their families and to the pediatric endocrinology community. The CommitteeUs favorable decision brings us one step closer to providing these patients a safe and effective treatment for their short stature."
The FDA Advisory Committee's recommendation is based on results of studies completed and jointly presented by Genentech and Eli Lilly. The companies agreed to a collaborative presentation of clinical trial data in order to provide the most complete information to the FDA Advisory Committee on growth hormone therapy for short stature associated with Turner syndrome. The Committee commended Genentech and Eli Lilly for their collaborative efforts and recommended that the companies continue to study the action of human growth hormone in Turner syndrome.
Genentech currently markets three human growth hormone products in the United States: Protropin® (somatrem for injection), Nutropin[somatropin (rDNA origin) for injection], and Nutropin AQ® [somatropin (rDNA origin) injection] for growth failure due to inadequate growth hormone secretion; and Nutropin and Nutropin AQ for children with growth failure associated with chronic renal insufficiency up to the time of renal transplantation.
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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