From rxpgnews.com
Mecasermin rinfabate Granted Priority Review Status for the Treatment of Growth Hormone Insensitivity Syndrome
By Insmed Incorporated
Apr 14, 2005, 20:49
Insmed Incorporated (NASDAQ: INSM) announced today that the Company has received Priority Review notification from the U.S. Food and Drug Administration (FDA) for the New Drug Application (NDA) for its drug candidate SomatoKine (mecasermin rinfabate). The FDA has notified the Company that the User Fee Goal Date is July 3, 2005.
The FDA previously granted SomatoKine, 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.
More on SomatoKine(R)
Insmed's SomatoKine(R) is a proprietary delivery composition of insulin-like growth factor-I (IGF-I) and its principal binding protein, IGFBP-3.
The novel compound is administered as a single daily subcutaneous injection, which can restore IGF levels into the normal range.
On March 10 Insmed announced that the FDA had accepted Insmed's NDA submission for SomatoKine(R) for the treatment of Growth Hormone Insensitivity Syndrome (GHIS). Previously, Insmed provided the results from a six-month data analysis of the ongoing pivotal Phase III GHIS clinical trial showing a statistically significant increase (p less than 0.0001) in height velocity in children receiving SomatoKine(R) as a once-daily injection. In diabetic subjects, administration of SomatoKine(R) 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(R) 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(R) has demonstrated a significant improvement in functional recovery and bone mineral density.
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