Insmed Incorporated has received the acceptance to file notification from the US FDA for the New Drug Application (NDA) for its drug candidate SomatoKine (mecasermin rinfabate), a novel once-daily IGF-I therapy for the treatment of growth hormone insensitivity syndrome (GHIS). It is expected that the FDA will take action on the application no later than November 3, 2005, the company said here.
SomatoKine, an IGF-I therapy which was granted orphan drug designation by FDA, is a proprietary delivery composition of insulin-like growth factor I (IGF-I). The novel compound is administered as a subcutaneous injection, which can restore IGF-I levels to physiologically relevant levels. On July 20, Insmed provided the top-line results from a six-month data analysis of the pivotal Phase III GHIS clinical trial showing a statistically significant increase in height velocity in children receiving SomatoKine as a once-daily injection.
In diabetic subjects, administration of SomatoKine demonstrated a significant improvement in blood sugar control and a significant reduction in daily insulin use.