Wednesday, Nov 17, 1993
South San Francisco, Callf. -- November 17, 1993 --Genentech, Inc. announced today that it has received approval from the U.S. Food and Drug Administration (FDA) to market Nutropin? [somatropin (rDNA origin) for injection], its new recombinant human growth hormone (hGH), less than a month after receiving a unanimous recommendation for approval from an FDA Advisory Commiffee. Nutropin is indicated for treatment of growth failure in children due to chronic renal insufficiency (CRI) prior to kidney transplantation.
Nutropin is the first effective therapy to treat the severe growth retardation that results from CRI, which affects about 3,000 children in the United States. Kidney transplants can help a child start growing normally again, but most children do not make up the growth lost prior to transplantation.
"The rapid review and approval of Nutropin is great news for children with CRI who, until now, did not have any other way to help them grow normally before transplantation, said G. Kirk Raab, Genentech's president and chief executive officer. "We are very pleased that the FDA's Endocrinologic and Metabolic Drugs Division gave Nutropin priority attention for this orphan indication, because it allows us to make the drug available much earlier than expected to patients who need it. It's another example of how the Orphan Drug Act is working to benefit patients with unmet medical needs."
Genentech anticipates Nutropin will be available through pediatric nephrologists and pediatric endocrinologists by the end of the year.
In clinical trials, height in the normal range was achieved by 65 percent of children treated with Nutropin for two years and 91 percent of children treated for at least three years. The safety profile of Nutropin during clinical trials did not differ substantially from that reported for Genentech's other marketed growth hormone product, Protropin, for growth hormone inadequacy, which has been well-documented in more than 16,000 patients treated in the United States since 1985. Progression of renal disease was not altered by Nutropin therapy. Genentech will continue to monitor the long-term efficacy and safety of Nutropin in children with CRI in Phase IV postmarketing surveillance studies.
"This is an important advance for children with CRI, said Richard N. Fine, M.D., professor and chairman of pediatrics, State University of New York at Stony Brook, and one of the principal investigators of Nutropin during clinical trials. "The issue of growth retardation will now be minimized, where before it was a major clinical consequence of kidney failure in children..
Nutropin is produced by Genentech using recombinant DNA technology and has the same amino acid sequence as hGH produced naturally in the human body.
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, Calif., and is traded on the New York and Pacific Stock Exchanges under the symbol GNE.
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