Serono Laboratories, Inc. launches Geref® Growth Hormone Releasing Hormone For Idiopathic GH Deficiency
NORWELL, MA -- April 27, 1998 – Serono Laboratories, Inc. has launched Geref® (sermorelin acetate for injection), the first growth hormone releasing hormone for the treatment of idiopathic growth hormone deficiency (GHD) in children and Geref® Diagnostic (sermorelin acetate for injection), a complementary product for the diagnosis of growth disorders in the United States.
GHD results from either an abnormally low level of pituitary human growth hormone (hGH) or from a biochemical malfunction whereby growth hormone releasing hormone (GHRH) fails to trigger the release of hGH from the anterior pituitary. In the latter case, children with GHD may have endogenous hGH reserves which remain untapped.
As a growth hormone releasing hormone, Geref triggers the release of available reserves so that they can be used by the body. Traditionally, GHD has been treated by substituting natural hGH with a recombinant human growth hormone (r-hGH) product.
According to a study which appeared in the July 1994 Journal of Pediatrics, growth hormone deficiency, 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 are not diagnosed and treated until about age 10 -- a delay which clearly may prevent children from attaining their maximum growth potential.
"It is widely believed that treatment should begin early for a child to reach his or her full growth potential, and there are some data to support the initiation of treatment before age five," said Michael Thorner, M.D., a leading expert on growth and chairman of the department of medicine at the University of Virginia Health Sciences Center.
In total, GHD affects an estimated 13,000 children in the U.S., according to the Human Growth Foundation.
Geref Diagnostic, is a tool for detecting the cause of a child's slow growth and can be used either prior to Geref treatment or as a stand-alone diagnostic agent. With currently available diagnostic tests, physicians are unable to differentiate between hypothalamic and pituitary dysfunction, both of which impact growth. By directly stimulating the pituitary to release growth hormone, Geref Diagnostic clarifies the source of slow growth and enables a more accurate diagnosis. While it is known that many children with GHD have natural growth hormone reserves, until now it has been impossible to distinguish them from those children who lack growth hormone or whose natural supplies are inadequate.
"Geref and Geref Diagnostic add a new dimension to the diagnosis and treatment of GHD," Dr. Thorner said. "We will now be able to identify and more appropriately treat children whose GHD results from the body's failure to release hGH."
Geref(R) (sermorelin acetate for injection) has demonstrated a favorable safety profile. The most common adverse reactions include local injection reactions (occurring in about one patient in six) characterized by pain, swelling or redness. During clinical trials, only three of 350 patients discontinued therapy due to injection reactions. Other treatment-related adverse events with occurrence rates of less than one percent include: headache, flushing, dysphagia, dizziness, hyperactivity, somnolence and urticaria.
A large portion of patients developed anti-GRF antibodies at least once during treatment with Geref. However, the significance of the antibodies is not clear. The presence of these antibodies does not appear to affect growth or be related to a specific adverse reaction profile and no generalized allergic reactions to Geref have been reported.
Adverse reactions reported with the use of Geref(R) Diagnostic (sermorelin acetate for injection), in decreasing order of frequency are: transient warmth and/or flushing of the face, injection site pain, redness and/or swelling at injection site, nausea, headache and vomiting. Approximately one in four patients given repeated doses of Geref Diagnostic has developed antibodies -- the clinical significance of these antibodies is unknown.
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