From rxpgnews.com
Mecasermin Rinfabate for Growth Hormone Insensitivity Syndrome
By Akanksha, Pharmacology Correspondent
Mar 11, 2005, 07:12
Insmed Incorporated announced today that the Company has received the acceptance to file notification from the U.S. Food and Drug Administration (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 mecasermin rinfabate, an IGF-I therapy, orphan drug designation, a designation conferred upon investigational products for diseases that affect fewer than 200,000 patients in the United States. Products with orphan drug designation that are the first to be approved for a specific indication have seven years market exclusivity within the United States.
Mecasermin rinfabate 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 (p less than 0.0001) in height velocity in children receiving mecasermin rinfabate as a once-daily injection.
In diabetic subjects, administration of mecasermin rinfabate 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 mecasermin rinfabate 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 mecasermin rinfabate demonstrated a significant improvement in functional recovery and bone mineral density.
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