Delcath wins FDA nod for Melphalan

Delcath (NSDQ:DCTH) said today it won Orphan Drug Designation from the FDA for melphalan, used in its hepatic delivery system to treat cholangiocarcinoma. Orphan drug designations are bestowed by the FDA on treatments for “orphan diseases”, usually defined as conditions that affect fewer than 200,000 people nationwide. The designation comes with benefits, such as tax credits, exclusivity and a waived New Drug Application user fee. The drug is at the heart of Delcath’s hepatic delivery system, a chemotherapy system that delivers the melphalan to a patients liver to treat intrahepatic cholangiocarcinoma, or tumors in the bile duct within the liver, the company said. The hepatic system is designed to isolate the liver from the rest of the circulatory system and saturate it with melphalan chloride, then remove the drug from the patient’s blood before restoring the connection. “We are pleased with the receipt of orphan drug designation for melphalan in the treatment of patients with cholangiocarcinoma as it is a key milestone that supports our broader regulatory and development strategy for our Melphalan/Hepatic delivery system as a therapy for primary and metastatic liver cancers. ICC is a disease of significant unmet medical need and our Melphalan/HDS treatment may offer clinical benefit for ICC patients who face limited treatment options,” CEO Jennifer Simpson said in a press release. Intrahepatic cholangiocarcinoma is the 2nd most common l...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Drug Pumps Food & Drug Administration (FDA) Regulatory/Compliance Delcath Systems Inc. Source Type: news