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Tercica rhIGF-1 short stature study

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Tercica began a Phase IIIb study of its recombinant human insulin-like growth factor-1 (rhIGF-1) in children with short stature caused by primary IGF-1 deficiency Oct. 28. The two-year study, which "will be the basis of a future regulatory filing," will enroll 160 pre-pubertal children whose height and IGF-1 levels are more than two standard deviations below normal. Primary endpoint is change in height SD over one year. Tercica plans to file a separate rhIGF-1 NDA in "early 2005" for severe primary IGF deficiency, a subset of patients whose height and serum IGF-1 levels are more than three standard deviations below normal. Thirty-thousand children have primary IGFD in the U.S., of which 6,000 have the severe form, Tercica estimates...

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