New Therapy Significantly Reduces Number of Injections Required
Based on research conducted at Mattel Children's Hospital at UCLA and other research institutions nationwide, the U.S. Food and Drug Administration (FDA) Thursday approved the first long-acting dosage form of recombinant growth hormone for pediatric growth hormone deficiency (GHD).
In clinical trials, Nutropin Depot [somatropin (rDNA origin) for injectable suspension] was shown to significantly increase growth rates in children with GHD. The new formulation requires only one or two doses a month (which may require more than one injection per dose), compared with current growth hormone therapies that require multiple doses per week (oftentimes daily).
"Nutropin Depot, a convenient new treatment option, offers my newly diagnosed patients excellent growth potential with 12 or 24 doses a year, instead of 365," said Dr. Mitchell Geffner, UCLA chief of pediatric endocrinology and a principal investigator of the drug at the Mattel Children's Hospital at UCLA.
Nutropin Depot is a long-acting form of Genentech's recombinant human growth hormone (rhGH) using Alkermes' ProLeaseŇ injectable extended-release drug delivery system. The new formulation was designed to reduce the frequency of injections by encapsulating the drug in biodegradable microspheres.
In clinical studies, Nutropin Depot was tested for safety, tolerability and efficacy in children with GHD. Ninety-one patients enrolled at 30 sites in the United States were administered the same total dose of Nutropin Depot -- given once monthly or divided into two equal doses given twice monthly.
The most common adverse effects associated with subcutaneous injections of Nutropin Depot were injection-site reactions (53 percent), which occurred in nearly all patients and included redness; post-injection site pain (47%); and nodules (61%). These side effects all resolved without further intervention. Nutropin Depot should not be used in patients with active tumors or acute critical illness due to complications following open heart or abdominal surgery, multiple accidental trauma or to patients having acute respiratory failure.
Growth hormone deficiency, GHD, is a pituitary disorder resulting in short stature and other physical ailments. It affects approximately 20,000 children nationwide. GHD occurs when the production of growth hormone, secreted by the pituitary gland, is disrupted. Since growth hormone plays a critical role in stimulating body growth and development, and is involved in the production of muscle protein and in the breakdown of fats, a decrease in the hormone affects numerous body processes.
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