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FDA Grants Clearance To New Treatment For Growth Hormone Deficiency NORWELL, MA. -- October 3, 1997 -- The U.S. Food and Drug Administration granted marketing clearance to Serono Laboratories, Inc.’s Geref(R) (sermorelin acetate for injection), growth hormone releasing hormone (GHRH). Geref is indicated for growth hormone deficiency (GHD) in children and offers a new alternative for their treatment. GHD results from either abnormally low levels of pituitary human growth hormone (hGH) or from failure of the hypothalamus to stimulate the pituitary to release hGH reserves. In a healthy child, natural GHRH serves as the trigger for the hypothalamus, which generates the release of hGH through a signal to the pituitary gland. Geref acts as a replacement for naturally occurring GHRH. Traditionally, GHD has been treated by administering recombinant human growth hormone (r-hGH) as a substitute for the naturally occurring hormone. "Geref is truly a milestone in the treatment of growth disorders. With Geref, we can now take advantage of the body's own resources to stimulate growth," said Hisham Samra, M.D., president of Serono Laboratories. "In approximately 80 percent of cases, growth hormone deficient children actually have some natural hGH reserves and for appropriate candidates, treatment with Geref provides a novel treatment approach." Geref will be marketed directly to approximately 500 pediatric endocrinologists and will be provided to distributors upon request. Serono, a leader in the treatment of growth disorders, also markets Saizen(R) (somatropin [rDNA origin] for injection), in the United States for pediatric growth hormone deficiency. Saizen acts as a replacement for human growth hormone. In total, Saizen is available in 69 countries and, outside the United States, is indicated for a number of growth disorders in children. According to a study which appeared in the July 1994 Journal of Pediatrics, GHD, which inhibits skeletal growth, occurs in one out of every 3,500 children. Although GHD can be detected in infancy, most children who have the disorder do not begin therapy until about the age of 10 -- a delay which may prevent children from attaining their maximum growth potential. In total, GHD impacts an estimated 15,000 children in the United States, according to The Human Growth Foundation. E-mail this page to a friend or colleague! To print, use this version