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Neurochem's eprodisate (KIACTA(TM)) PDUFA date extended three months by FDA
Neurochem's eprodisate (KIACTA(TM)) PDUFA date extended three months by FDA.
About this update from Bluenergies Ltd.
[{"type":"text","content":"\n\n\n\nECUBLENS, Switzerland, April 11 /CNW Telbec/ - Neurochem (International)\nLimited (Neurochem), a wholly owned subsidiary of Neurochem Inc.\n(NASDAQ: NRMX; TSX: NRM), announces that it received notification from the\nUnited States Food and Drug Administration (FDA) that the action date for\nFDA's review of the New Drug Application (NDA) for eprodisate (KIACTA(TM)) for\nthe treatment of Amyloid A (AA) amyloidosis, has been extended to July 16,\n2007. Previously, the action date under the Prescription Drug User Fee Act\n(PDUFA) for the eprodisate (KIACTA(TM)) NDA was April 16, 2007.\n\n\nThe FDA is extending the PDUFA goal date by three months to provide time\nfor a full review of an amendment to the eprodisate (KIACTA(TM)) NDA submitted\nby Neurochem Inc. in February 2007. This additional submission is considered\nby the FDA to be a major amendment to the NDA, allowing an extension of the\naction date.\n\n\nAbout eprodisate (KIACTA(TM))\n\n\nEprodisate (KIACTA(TM)) was investigated in a landmark international,\nrandomized, double-blind, placebo-controlled, and parallel-designed 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 five years. Eprodisate (KIACTA(TM)) has received orphan drug\nstatus in the United States, the European Union and in Switzerland.\n\n\nAbout Amyloid A (AA) Amyloidosis\n\n\nA progressive and fatal condition, AA amyloidosis occurs in a proportion\nof patients with chronic inflammatory disorders, chronic infections and\ninherited diseases such as Familial Mediterranean Fever. The kidney is the\norgan most frequently affected and progression to dialysis/end-stage renal\ndisease is the most common clinical manifestation in this disease. Currently,\nthere is no approved therapy to treat AA amyloidosis and about half of all\npatients diagnosed with the disease die within five years of diagnosis.\n\n\nThe EFATT study was sponsored by Neurochem Inc.\n\n\nAbout Neurochem\n\n\nNeurochem Inc. is focused on the development and commercialization of\ninnovative therapeutics to address critical unmet medical needs. Eprodisate\n(KIACTA(T...