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| |  Ready-To-Use Nutropin AQ Approved For Adult Growth Hormone Deficiency SOUTH SAN FRANCISCO, CA -- December 19, 1997 -- The United States Food and Drug Administration (FDA) has granted marketing clearance to Genentech, Inc.’s Nutropin AQ(R) -- the only liquid (aqueous) recombinant human growth hormone product which does not require reconstitution of a freeze-dried powder -- for the replacement of endogenous growth hormone (GH) in patients with adult growth hormone deficiency (GHD). Earlier this week, Genentech received clearance to market Nutropin(R) -- its original lyophilised (powdered) product -- for adult GHD. Somatropin replacement therapy (SRT) is recommended for adults who meet specific criteria including a diagnosis of GHD by means of a subnormal response to a standard growth hormone stimulation test as well as the experience of adult GHD due to pituitary disease, tumour or trauma, or from childhood-onset of the condition. It is important that children diagnosed with GHD and treated with growth hormone are retested after they achieve adult height. "Somatropin replacement therapy has been shown to improve some of the symptoms of adult growth hormone deficiency such as altered body composition and abnormal lipid metabolism," said Lawrence Phillips, MD, professor of medicine and director of the division of endocrinology and metabolism at Emory University. "It's important to replace what is missing -- similar to replacement therapies for other hormone deficiencies." Two trials were conducted -- one looking at patients with childhood-onset GHD and the other observing patients with adult-onset GHD. In clinical trials designed to assess the effects of SRT in adults with GHD, both studies showed that patients receiving SRT experienced significant decreases in total body percent fat and trunk percent fat with increases in percent lean mass. In the adult-onset study, patients with adult GHD who were treated with SRT demonstrated a statistically significant decrease in LDL cholesterol compared to the placebo group, resulting in significant improvement in LDL:HDL ratio -- an indicator of cardiac risk. There were no statistically significant differences from placebo for total cholesterol, HDL cholesterol or triglycerides. In the childhood-onset study, significant decreases in total cholesterol, LDL cholesterol and LDL:HDL were seen in the high dose SRT group only, compared to placebo. There were no statistically significant differences in HDL cholesterol or triglycerides. The most common side effects reported by GH deficient adults were dose related and included edema or swelling (41 percent Nutropin versus 25 percent placebo patients), joint pain (27 percent Nutropin versus 15 percent placebo) and carpal tunnel syndrome. In GH deficient adults, Nutropin was associated with an increase of insulin levels. Therefore, patients with diabetes should be monitored closely. Nutropin AQ and Nutropin should not be used in patients with active tumours. Experience with prolonged GH treatment in adults is limited. The company currently markets Nutropin AQ and Nutropin in the U.S. for children with growth failure due to inadequate growth hormone secretion, for children with growth failure associated with chronic renal insufficiency up to the time of renal transplantation and for the long-term treatment of short stature associated with Turner syndrome. Nutropin AQ and Nutropin should not be used for growth promotion in pediatric patients with closed epiphyses (for example, patients with no remaining growth potential) or in patients with active tumours.
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