Home » Drug Information » FDA-Approved Drugs » 1997
Medical Areas: Endocrinology
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Drug Information
The following information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Company: Pharmacia & Upjohn
Approval Status: Approved November 1997
Treatment Area: growth hormone deficiency
Genotropin Lyophilized Powder (somatropin rDNA origin) has been
approved for the treatment of growth hormone deficiency in
adults.
In vitro, preclinical, and clinical studies have demonstrated
that Genotropin is therapeutically equivalent to human growth
hormone of pituitary origin. In six placebo-controlled clinical
studies of 172 GHD adults, 85 of whom received Genotropin, lean
body mass, total body water, and lean/fat ratio all increased while
total body fat mass and waist circumference decreased after six
months. These effects on body composition were maintained when
treatment was continued beyond six months. Bone mineral density
declined after six months of treatment but returned to baseline
values after 12 months.
Growth hormone deficiency occurs when the pituitary gland does
not secrete sufficient amounts of endogenous growth hormone. Adults
may acquire this condition as a result of treatment of pituitary
tumors, or from other medical conditions resulting in
hypopituitarism; it can also be a continuation of childhood-onset
growth hormone deficiency.