Delcath Systems, Inc. (Nasdaq: DCTH) today announced that the Company has submitted the remaining modules of its 505(b)(2) New Drug Application (NDA) for its proprietary chemosaturation system to the U.S. Food & Drug Administration (FDA). The Company had previously submitted Module 4, consisting of literature based non-clinical data, to the FDA in late April 2010. The Company is seeking an indication for the percutaneous intra-arterial administration of melphalan hydrochloride for use in the treatment of patients with metastatic melanoma in the liver.
“Our team has achieved a significant milestone with the filing of our NDA,” said Eamonn P. Hobbs, CEO & President of Delcath Systems. “We believe that our application is comprehensive and complete, and we are optimistic that it will be accepted for review by the FDA. Considering the limitations of current treatment options, we believe the chemosaturation system can offer hope to patients with metastatic melanoma in the liver. We have requested priority review of our NDA by the FDA, which if granted could result in a 6-month review of the application. Priority review is granted by the FDA to those products that address significant unmet medical needs or have the potential to provide significant improvement compared to marketed products. With the strength of our Phase III data, we believe that our application meets the FDA’s criteria for priority review.”
The FDA normally requires 60 days to perform a cursory review and assess whether the NDA is sufficiently complete to warrant a substantive review and issue a Prescription Drug User Fee Act (PDUFA) action date. Delcath intends to make further announcements as the review proceeds, including the FDA’s response to the application and potential determination of a PDUFA action date.
SOURCE Delcath Systems, Inc.