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NPS teduglutide enters Phase III

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

NPS is initiating a six-month pivotal Phase III study of its short bowel syndrome agent teduglutide, the firm announces April 6. The double-blind, placebo-controlled study will randomize 80 patients to 0.05 mg or 0.1 mg/kg/day subcutaneous teduglutide, with a primary endpoint of reduction of intravenous feeding. The glucagon-like peptide 2 analog is also in Phase II for Crohn's disease. Teduglutide has orphan drug status for SBS; the firm estimates approximately 16,000 to 20,000 adults in the U.S. have the condition. Serono's human growth hormone Zorbtive (somatropin) cleared FDA for SBS Dec. 1, 2003; launch is planned for 2004...
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