Second Approvable Letter Delays Ruling on Amyloidosis Drug

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Neurochem Inc., of Quebec, Canada, has received a second approvable letter from the FDA for Kiacta (eprodisate) for the treatment of amyloid A (AA) amyloidosis. While a clinical trial showed evidence of the effectiveness of Kiacta in treating renal manifestations of amyloidosis, an additional efficacy trial is necessary before FDA approval could be given unless additional submissions of data by Neurochem addressed the issues raised. The kidney is most frequently affected by AA amyloidosis, a progressive and fatal condition occurring in patients with chronic inflammatory disorders, chronic infections and inherited diseases such as familial Mediterranean fever. Progression to end-stage renal disease is the most common clinical manifestation of the disease. There is no approved therapy for AA amyloidosis. About half of all patients diagnosed with the disease die within five years.

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