FDA Accepts Tercica's New Drug Application for Increlex

Tercica has announced that the FDA has accepted for filing and granted priority review of the company's New Drug Application (NDA) for Increlex, or recombinant human insulin-like growth factor-1 (rhIGF-1). The company is seeking approval to market Increlex (mecasermin [rDNA origin] injection) for the long-term treatment of short stature caused by a severe form of primary IGF-1 deficiency (Primary IGFD). Based on the Priority Review designation, the FDA has six months from the submission date, by August 31, 2005, to take action on the NDA filing.

Tercica submitted the NDA for Increlex in a fully electronic format (i.e. an eCTD) to the FDA on February 28, 2005. The NDA is based upon the results of a 71-child Phase III clinical trial of rhIGF-1 for the treatment of short stature caused by Severe Primary IGFD. Data from the study, presented in June 2004 at the 86th Annual Meeting of The Endocrine Society, demonstrated a statistically significant increase in growth rate over an eight-year period in response to therapy.