iPlexTreatment for Primary IGF-1 Deficiency
Insmed Receives Approvable Letter for iPlex
RICHMOND, Va., September 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.
The Approvable Letter Insmed received is an official notification that the FDA has completed the review of the iPlex New Drug Application (NDA) and has found the application to be sufficiently complete for full approval pending the submission of additional information primarily regarding the Chemistry, Manufacturing and Controls (CMC) section of the application. FDA is not requiring the Company to conduct additional preclinical or clinical trials. FDA has informed Insmed that they are still considering iPlex's orphan exclusivity status.
"The Company plans to rapidly respond to these questions and work with the Agency to resolve all outstanding issues. I look forward to the completion of our work with the FDA so that we may bring this product to the clinic, and provide caregivers with this important therapeutic option for their patients", added Geoffrey Allan, Ph.D., President and Chief Executive Officer of Insmed.
"Based on my experience with therapies for a variety of growth disorders, it is clear that the pediatric endocrine community will welcome this alternative therapy. Throughout the clinical development program, iPlex therapy has demonstrated a very favorable safety profile, in addition to the robust growth response," commented Kenneth Attie, M.D. Chief Medical Officer for Insmed.
Source: Insmed Incorporated.
Posted: September 2005
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- 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
- 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