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Neurochem moves eprodisate (KIACTA(TM)) drug development program forward for Amyloid A amyloidosis
ECUBLENS, SWITZERLAND, March 13 /CNW Telbec/ - Neurochem (International) Limited (Neurochem), a w...
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[{"type":"text","content":"\n\n\n\nECUBLENS, SWITZERLAND, March 13 /CNW Telbec/ - Neurochem (International)\nLimited (Neurochem), a wholly-owned subsidiary of Neurochem Inc. (NASDAQ:\nNRMX; TSX: NRM), announces that the Company is taking new initiatives to\npursue the drug development program for its investigational product candidate,\neprodisate (KIACTA(TM)), to obtain market approval for the treatment of\nAmyloid A (AA) amyloidosis. Neurochem's decision to build upon its eprodisate\n(KIACTA(TM)) asset and take steps to initiate a second Phase III clinical\ntrial is based principally on the fact that AA amyloidosis is a\nlife-threatening disease for which there is no specific treatment, on the data\nobtained from the first Phase II/III clinical trial, which yielded promising\nefficacy results on the study endpoints, on the benign safety profile of\neprodisate (KIACTA(TM)) in patients diagnosed with AA amyloidosis, and on its\ndiscussions with the regulatory agencies and related scientific advisory\ncommittees. As part of the approval process for the investigational product\ncandidate, both the regulatory agencies in the United States and in the\nEuropean Union recommended an additional confirmatory efficacy Phase III\nclinical trial, which will have a target significance level (p-value) of\n0.05 rather than the p-value of 0.01, which had been required for an approval\nbased on a single efficacy study. Based on these recommendations, the Company\nwill enter into discussions with the U.S. Food and Drug Administration (FDA)\nand with the European Medicines Agency (EMEA) to reach agreement on the terms\nfor an approval of eprodisate (KIACTA(TM)) for the treatment of\nAA amyloidosis. As part of this strategic decision, the Company is also\nannouncing that it is withdrawing its current marketing applications for\neprodisate (KIACTA(TM)) in the United States, the European Union and\nSwitzerland.\n\n\n"This strategy reflects the advice the Company has received from the\nregulatory authorities about its marketing applications, and is in line with\nour efforts over the past two years and allows the Company to pursue its\nobjective of making KIACTA(TM) available to patients as soon as possible. The\nFDA and EMEA have both acknowledged that the first Phase II/III clinical trial\nprovided some evidence of the effectiveness of KIACTA(TM) in the treatment of\nthe ...