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Neurochem announces European opinion for Eprodisate (KIACTA(TM)) for the treatment of AA amyloidosis
ECUBLENS, Switzerland, Dec. 14 /CNW Telbec/ - Neurochem (International) Limited (Neurochem), a wh...
About this update from Bluenergies Ltd.
[{"type":"text","content":"\n\n\n\nECUBLENS, Switzerland, Dec. 14 /CNW Telbec/ - Neurochem (International)\nLimited (Neurochem), a wholly-owned subsidiary of Neurochem Inc. (NASDAQ:\nNRMX; TSX: NRM), announces that the Committee for Medicinal Products for Human\nUse (CHMP), the scientific committee of the European Medicines Agency (EMEA),\nhas issued a negative opinion recommending refusal of the marketing\nauthorization application (MAA) for eprodisate (KIACTA(TM)) for the treatment\nof Amyloid A (AA) amyloidosis and concluding that another study would be\nneeded to demonstrate eprodisate's (KIACTA(TM)) effectiveness. The Company is\ncurrently reviewing all of its options in view of this opinion, including the\noption of requesting a re-examination of the opinion by CHMP. As provided by\nthe European regulations, the Company may request that the CHMP consult a\nScientific Advisory Group (SAG) in connection with the re-examination. The\ndeadline for filing any such request is within fifteen days of receipt of\nnotification of the opinion.\n\n\n"We are naturally disappointed with this opinion for KIACTA(TM) as we are\nacutely aware of the needs of AA amyloidosis patients who have no specific\ntherapy presently available," said Dr. Francesco Bellini, Neurochem Inc.'s\nChairman, President and CEO. "In view of the clinical benefit KIACTA(TM) has\nshown on the kidney function of patients, we are considering making a request\nfor re-examination of the opinion which could lead to a decision as early as\nthe second quarter of 2008. We look forward to further productive interactions\nwith the EMEA," he concluded.\n\n\nU.S. New Drug Application (NDA)\n\n\nIn the U.S., Neurochem Inc. received an acknowledgement from the Food and\nDrug Administration (FDA) that the Company's response to the second approvable\nletter of July 2007 for the NDA for eprodisate (KIACTA(TM)) for the treatment\nof AA amyloidosis is a complete, Class 2 response. The PDUFA (Prescription\nDrug User Fee Act) goal date by which the FDA is expected to render a decision\nis April 2, 2008.\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 international\nsites (Eprodisate for A...