Tercica Submits NDA for Increlex to Treat Short Stature

Tercica has submitted a new drug application in the electronic common technical document format to the FDA to market Increlex, recombinant human Insulin-like Growth Factor-1 (rhIGF-1), for the long term treatment of growth failure in children with a severe form of primary IGF-1 deficiency (Primary IGFD).

Insulin-like Growth Factor-1 (IGF-1) is the principal hormone necessary for statural growth. IGF-1 is released in response to stimulation by growth hormone. Primary IGFD is a disease characterized by lack of IGF-1 production in the presence of normal or elevated levels of endogenous growth hormone.

Primary IGFD afflicts an estimated 30,000 children evaluated for short stature in the U.S. Approximately 6,000 children suffer from a more severe form of this disease, called Severe Primary IGFD, and could become eligible for Increlex (mecasermin [rDNA origin] injection) therapy if approved by the FDA.