New drug/product updates
FDA approves growth drug
The Food and Drug Administration in Rockville, MD, recently granted orphan drug status for somatropin for injection in the long-term treatment of growth failure in children with Prader-Willi syndrome, a rare genetic disorder that causes short stature, an involuntary continuous urge to eat, low muscle tone, and cognitive disabilities.
In two randomized, open-label, controlled clinical trials, 23 children with Prader-Willi syndrome received somatropin. A control group received standard care. At the end of the first year of treatment, there was a clinically and
statistically significant difference in the mean change in height between the treatment and
control groups in both studies.
Body composition benefits
Linear growth continued in the second year when both the study groups and the control groups received treatment with somatropin. In addition, the drug produced beneficial effects on body composition at one year, with an increase in lean body mass and decrease in fat mass. There was no apparent impact on body weight.
In the United States, Genotropin Lyophilized Powder (somatropin [rDNA origin] for injection), manufactured by Pharmacia & Upjohn in Peapack, NJ, has been approved for the long-term treatment of children with growth hormone deficiency (GHD) since 1995 and adults with GHD of either childhood or adult onset since 1997.
Case managers with clinical questions about somatropin can call (800) 253-8600 or visit the company's Web site at www.genotropin.com.
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