iPlexTreatment for Primary IGF-1 Deficiency
FDA Accepts for Review Insmed's NDA for SomatoKine for the Treatment of Growth Hormone Insensitivity Syndrome
RICHMOND, Va., March 10, 2005 - Insmed Incorporated (NASDAQ: INSM) 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 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
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. 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<0.0001) 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. 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.
Insmed is a biopharmaceutical company focused on the discovery and development of drug candidates for the treatment of metabolic diseases and endocrine disorders with unmet medical needs.
For more information, please visit www.insmed.com.
Posted: March 2005
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- FDA Extends PDUFA Date for SomatoKine to October 3, 2005 - June 10, 2005
- Insmed Submits New Drug Application -NDA- to Seek Regulatory Approval of SomatoKine for the Treatment of Growth Hormone Insensitivity Syndrome - January 3, 2005