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 FDA previously granted SomatoKine, an IGF-I therapy, orphan drug designation in the United States.

Insmed's SomatoKine 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. Recently, 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.

According to the release, in diabetic subjects, administration of SomatoKine demonstrated a significant improvement in blood sugar control and a significant reduction in daily insulin use. Following severe burn injury, in both children and adults, administration of SomatoKine demonstrated a significant improvement in muscle protein synthesis and a significant reduction in the inflammatory response associated with the trauma. In recovery from hip fractures, administration of SomatoKine demonstrated a significant improvement in functional recovery and bone mineral density.