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Neurochem receives approvable letter for eprodisate (KIACTA(TM)) for treatment of AA amyloidosis
Neurochem receives approvable letter for eprodisate (KIACTA(TM)) for treatment of AA amyloidosis.
About this update from Bluenergies Ltd.
[{"type":"text","content":"\n\n\n\nECUBLENS, Switzerland, July 17 /CNW Telbec/ - Neurochem (International)\nLimited (Neurochem), a wholly-owned subsidiary of Neurochem Inc. (NASDAQ:\nNRMX; TSX: NRM), announces that the Company has received a second approvable\nletter from the United States Food and Drug Administration (FDA) for\neprodisate (KIACTA(TM)) for the treatment of Amyloid A (AA) amyloidosis.\n\n\nIn its action letter, the FDA indicates that the Phase II/III clinical\ntrial provided some evidence of the effectiveness of eprodisate (KIACTA(TM))\nin the treatment of the renal manifestations of amyloidosis; however, the FDA\nalso indicated that an additional efficacy trial with a target p-value of\n0.05 will be necessary before the FDA could approve the investigational\nproduct candidate. Further, the approvable letter states that additional\nsubmissions, filed by Neurochem as part of its complete response to this\napprovable letter, may address issues raised in this letter. The FDA has\nindicated that such additional submissions could persuade the agency to\neliminate the requirement for an additional trial.\n\n\nThe FDA also asked for additional information, including further\npharmacokinetic studies, and again acknowledged that a QT clinical study\nshould be submitted as part of a Phase IV (post-approval) commitment.\n\n\nThe Company expects to file a complete response to this approvable letter\nin the near future.\n\n\n"We are disappointed that the FDA has not yet approved KIACTA(TM). This\nis a rare disease with no specific treatment available for the patients,"\ncommented Dr. Francesco Bellini, Neurochem's Chairman, President and CEO. "We\nwill continue to work closely with the agency with the hope of securing final\napproval of this product candidate," he concluded.\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 five years. Eprodisate (KIACTA(TM)) has received o...