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Neurochem announces eprodisate (KIACTA(TM)) receives acknowledgement of complete response and is granted Class 2 review
ECUBLENS, Switzerland, Dec. 6 /CNW Telbec/ - Neurochem (International) Limited (Neurochem), a who...
About this update from Bluenergies Ltd.
[{"type":"text","content":"\n\n\n\nECUBLENS, Switzerland, Dec. 6 /CNW Telbec/ - Neurochem (International)\nLimited (Neurochem), a wholly-owned subsidiary of Neurochem Inc. (NASDAQ:\nNRMX; TSX: NRM), announces that the Company has received an acknowledgement\nfrom the United States Food and Drug Administration (FDA) that Neurochem's\nresponse to the July 2007 approvable letter for the New Drug Application (NDA)\nfor eprodisate (KIACTA(TM)) for the treatment of Amyloid A (AA) amyloidosis is\na complete, Class 2 response. The PDUFA (Prescription Drug User Fee Act) goal\ndate by which the FDA is expected to render a decision is April 2, 2008.\n\n\nThe NDA for approval of eprodisate (KIACTA(TM)) for the treatment of AA\namyloidosis was filed in February 2006. The Company submitted its response to\nthe second approvable letter last September and this response has been\nacknowledged as complete by the FDA, allowing for the Class 2 review.\n\n\n"We look forward to further productive interactions with the FDA as we\nenter late-stage discussions on our marketing application," said Dr. Francesco\nBellini, Neurochem Inc.'s Chairman, President and CEO.\n\n\nAbout eprodisate (KIACTA(TM))\n\n\nEprodisate (KIACTA(TM)) was investigated in an international, randomized,\ndouble-blind, placebo-controlled, and parallel-designed Phase II/III clinical\ntrial in which 183 AA amyloidosis patients were enrolled at 27 sites around\nthe world (Eprodisate for AA Amyloidosis Trial, EFAAT). Patients who completed\nthe clinical trial were eligible for enrollment in an ongoing open-label\nextension study, some of whom have now been receiving eprodisate (KIACTA(TM))\nfor more than six years.\n\n\nIn September 2006, the European Medicines Agency (EMEA) confirmed that it\nhad commenced a regulatory review of eprodisate (KIACTA(TM)). The Marketing\nAuthorization Application is being reviewed under the Agency's centralized\nprocedure. This means that an authorization from this Agency would apply to\nall 27 European Union member states, as well as to Norway and Iceland. An oral\nhearing occurred with the EMEA in November 2007 to discuss outstanding issues\nraised with respect to the eprodisate (KIACTA(TM)) application and a decision\nfrom the EMEA is expected by year-end, or shortly thereafter.\n\n\nThe Company also filed for marketing approval for eprodisate (KIACTA(TM))\nfor the tr...