The result follows the FDA’s acceptance of Insumed’s response to an approvable letter issued by the authority seeking further clarification.
The submission is being made for iPlex, a mecasermin rinfibate (rDNA origin) injection, for the treatment of children with growth failure who suffer from severe primary IGF-1 deficiency (Primary IGFD).
The original approvable letter, issued in September 2005, indicated that the FDA had completed the review of the iPlex application and found the application to be sufficiently complete for full approval pending the submission of additional information primarily regarding the chemistry, manufacturing and controls section of the application.
The FDA is has not asked the company to conduct any additional preclinical or clinical trials. The FDA has not yet determined whether the approval and granting of orphan exclusivity for mecasermin (rDNA origin) for severe primary IGF-1 deficiency will block the approval of iPlex.