2. Duration of Therapy

Five clinical studies evaluated mecasermin use in 71 pediatric patients with severe primary IGF-1 deficiency (one double-blind, placebo-controlled trial and four open-label trials). Results revealed 61 patients completed at least one year of treatment and 13 patients received mecasermin therapy for 8 years. The mean change in height velocity significantly increased from baseline in mecasermin-treated patients for treatment years 1 through 6. Therapy continuation is recommended until epiphyses fuse and full growth potential is reached. However, a maximum treatment duration has not been defined for mecasermin^3-7.