iPlex Insmed Incorporated - Treatment for Severe Primary IGF-1 DeficiencyiPlex, mecasermin rinfabate, is the human recombinant of the naturally occurring protein complex of insulin-like growth factor-I (IGF-1) and insulin-like growth factor binding protein-3 (IGFBP-3). iPlex is indicated for the treatment of growth failure in children with severe primary IGF-1 deficiency (Primary IGFD) or with growth hormone (GH) gene deletion who have developed neutralizing antibodies to GH.
Posted: December 2005
- FDA to Review Insmed's Complete Response to Approvable Letter for iPlex - October 25, 2005
- Insmed Submits Response to FDA Approvable Letter for iPlex - October 17, 2005
- Insmed Receives Approvable Letter for iPlex - September 27, 2005
- FDA Extends PDUFA Date for SomatoKine to October 3, 2005 - June 10, 2005
- FDA Accepts for Review Insmed's NDA for SomatoKine for the Treatment of Growth Hormone Insensitivity Syndrome - March 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