iPlex
mecasermin rinfabate [rDNA origin]
Treatment for Primary IGF-1 DeficiencyFDA to Review Insmed's Complete Response to Approvable Letter for iPlex
RICHMOND, Va., October 25, 2005 - Insmed Incorporated (NASDAQ-NMS: INSM) (NASDAQ: INSM) announced today that the United States Food and Drug Administration (FDA) considers Insmed's submission of October 12, 2005 as a complete, class 1 response to the Approvable Letter for iPlex (mecasermin rinfibate (rDNA origin) injection), for the treatment of children with growth failure who suffer from Severe Primary IGF-1 deficiency (Primary IGFD). The FDA has established December 12, 2005 as its target to complete its 60-day review of the iPlex New Drug Application (NDA).
In September 2005, the FDA issued an Approvable Letter indicating that the FDA has completed the review of the iPlex 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. 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.
Source: Insmed Incorporated
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