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Tercica Presents Pharmacokinetic and Safety Data From Several Studies

June 6, 2005

Tercica presented data from several studies in poster sessions at the 87th Annual Meeting of the Endocrine Society. Some of these data are included in the company's new drug application (NDA) for recombinant human insulin-like growth factor-1 (rhIGF-1) for the treatment of short stature caused by primary IGF-1 deficiency (Primary IGFD). The NDA was accepted for priority review by the FDA on April 29.

Data presented include: results from a human pharmacokinetic study; results from a novel diagnostic test used to distinguish children who may be insensitive to the effects of growth hormone and therefore who likely have growth failure due to primary insulin-like growth factor-1 (IGF-1) deficiency (Primary IGFD). The company also presented human and animal safety data showing no evidence of immunotoxic effects with long-term rhIGF-1 treatment; and a life-time rhIGF-1 toxicology study in animals that demonstrated a reduction in the incidence of some endocrine cancers. These data provide further insight into the long-term safety of rhIGF-1 treatment.