Insmed Incorporated (INSM) Receives Approvable Letter For iPlex(TM)
10/19/2005 5:12:56 PM
RICHMOND, Va.--(BUSINESS WIRE)--Sept. 27, 2005--Insmed Incorporated (NASDAQ-NMS: INSM) (NASDAQ: INSM) announced today the receipt of an Approvable Letter from United States Food and Drug Administration (FDA) for iPlex(TM) (rhIGF-I/rhIGFBP-3) (Mecasermin rinfibate), for the treatment of children with growth failure who suffer from Severe Primary IGF-1 deficiency (Primary IGFD). Previously Insmed referred to its primary indication as Growth Hormone Insensitivity Syndrome (GHIS). Based on FDA input GHIS is now referred to as Severe Primary IGFD. iPlex is the new worldwide trade name for Insmed's proprietary combination of rhIGF-I/rhIGFBP-3 which was previously called SomatoKine.