Genentech Wins FDA Clearance of Ready-to-use Nutropin AQ for Growth Hormone Deficiency in Adults
Genentech, Inc. a leading supplier of U.S. growth hormone products, announced last week that Nutropin AQ—a liquid (aqueous) recombinant human growth hormone product that does not require reconstitution of a freeze-dried powder—received market clearance from the U.S. Food and Drug Administration for the replacement of endogenous growth hormone (GH) in patients with adult growth hormone deficiency (GHD).
In a separate announcement, Genentech announced that the company received clearance to market Nutropin—its original lyophilized (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, tumor or trauma, or from childhood onset of the condition.
"Research has shown growth hormone to play a significant role in adults, even if a person has reached his or her adult height," said Lawrence S. Phillips, M.D., professor of medicine and director of the division of endocrinology and metabolism at Emory University. "Clinical evidence indicates that adults who are fully grown need adequate levels of growth hormone."
In clinical trials designed to assess the effects of SRT in adults with GHD, two 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.
"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 Phillips. "It's important to replace what is missing—similar to replacement therapies for other hormone deficiencies."
The most common side effects reported by GH deficient adults were dose related and included edema or swelling and carpal tunnel syndrome. In GH deficient adults, Nutropin was associated with an increase of insulin levels. Nutropin AQ and Nutropin should not be used in patients with active tumors. Experience with prolonged GH treatment in adults is limited.
Genentech currently markets Nutropin AQ and Nutropin in the United States 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.