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Neurochem submits a complete response to FDA approvable letter for KIACTA(TM)
Neurochem submits a complete response to FDA approvable letter for KIACTA(TM).
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[{"type":"text","content":"\n\n\n\n\nECUBLENS, Switzerland, Oct. 16 /CNW Telbec/ - Neurochem (International)\nLimited (Neurochem), a wholly-owned subsidiary of Neurochem Inc. (NASDAQ:\nNRMX; TSX: NRM), announces today that it has submitted a complete response to\nthe U.S. Food and Drug Administration's (FDA) August 2006 approvable letter\nfor KIACTA(TM). The Company is seeking marketing approval of its\ninvestigational product candidate KIACTA(TM) (eprodisate; formerly \nFIBRILLEX(TM)) for the treatment of Amyloid A (AA) amyloidosis. Today, there\nis still no specific treatment for AA amyloidosis, a deadly disease which\noften destroys kidney function.\nThe complete response includes the data on safety and efficacy from a\nfollow-up of all 183 patients who were enrolled in the Phase II/III clinical\ntrial. Following the suggestion of the FDA in its approvable letter, Neurochem\nsuccessfully retrieved the most recent health information (i.e. dialysis/end\nstage renal disease (ESRD) or death from all causes, regardless of when the\nclinical event occurred) for all 183 study subjects, including patients\ncurrently enrolled in the open-label extension study and all patients who\ndiscontinued their participation in the study. The median time of follow-up\nwas approximately 36 months.\nThe statistical methodology, as discussed with the FDA, includes the\nanalysis (log-rank test) to compare the time required to progress to\ndialysis/ESRD and to progress to a composite endpoint of dialysis/ESRD or\ndeath (all causes) between the two groups originally randomized to either\nACTA(TM) or placebo(1). The results of the follow-up analysis included in\nthe complete response are the following:\n\n- Fewer patients progressed to dialysis/ESRD in the KIACTA(TM)\ngroup (18), versus in the placebo group (32). The Kaplan-Meier plot\nand log-rank analysis(2) showed that it took longer for the KIACTA(TM)\ngroup to progress to dialysis/ESRD than the placebo group (log-rank\ntest; p-value of 0.018).\n- The follow-up analysis on the composite endpoint of dialysis/ESRD or\ndeath was also in favor of the KIACTA(TM) group as fewer patients (32)\nprogressed to dialysis/ESRD or death versus the placebo group (44). The\nKaplan-Meier plot and log-rank analysis showed that it also took longer\nfor the KIACTA(TM) group to progress to dialysis/ESRD or death than the\nplacebo group (log-rank ...