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FDA Clears Somatropin for Use in Patients With Short Bowel Syndrome

ROCKLAND, Mass., Dec. 2 /PRNewswire-FirstCall/ -- Serono, Inc., the US affiliate of Serono S.A. , announced today that the U.S Food and Drug Administration (FDA) has approved Zorbtive™(1) [somatropin (rDNA origin) for injection] for use in the treatment of short bowel syndrome (SBS).

"We are delighted that the FDA has approved Zorbtive™ for treatment of short bowel syndrome," said James Sapirstein, Executive Vice President, Metabolic Endocrinology, Serono, Inc. "There has been a substantial clinical need for additional effective treatment options for patients with this rare condition. We are pleased that continued discussions with the FDA following an Advisory Committee meeting in June have resulted in our being able to bring this product to patients."

SBS is a rare, serious and potentially life-threatening condition that follows extensive surgical removal of portions of the small intestine as a treatment for acute or chronic disorders of the intestine. Removal of a large portion of the bowel results in impaired absorption of nutrients. Currently the standard treatment for SBS involves careful management of dietary intake and hydration, or where appropriate, a process referred to as parenteral nutrition in which patients are fed through an intravenous tube. On rare occasions, surgical transplant of the intestine may also be performed for this condition. There are an estimated 10,000-20,000 patients in the United States who are receiving intravenous parenteral nutrition for SBS.

In a randomized double-blind, controlled, parallel group Phase III clinical study, Serono's recombinant human growth hormone administered with specialized nutritional support was shown to significantly reduce patient dependence on total parenteral nutrition as measured by total volume, total calories and frequency of infusion. Serono's recombinant human growth hormone was granted an orphan drug designation for use in the treatment of patients with short bowel syndrome by the FDA Office of Orphan Products Development.

Additional Product Information

The most common adverse events associated with growth hormone therapy are mild to moderate muscle and joint pain and swelling/edema, which occur in a dose-related manner and often subside with continued treatment or dose reduction. Cases of new onset impaired glucose intolerance, new onset type 2 diabetes mellitus and exacerbation of preexisting diabetes mellitus have been reported. Some patients develop diabetic ketacidosis and diabetic coma. In some patients, therapy with growth hormone necessitates initiation or adjustment of anti-diabetic treatment. Patients with a history of hyperglycemia or other risk factors for glucose intolerance should be monitored closely. Transient increases in glucose levels occur early in treatment and should be monitored.

Use of growth hormone is contraindicated in treatment of patients in intensive care units due to complications following open-heart surgery or abdominal surgery, multiple accidental trauma or acute respiratory failure; patients with active neoplasia; and patients with known hypersensitivity to growth hormone.

Source: Serono, Inc.

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