Neurochem announces eprodisate (KIACTA(TM)) receives acknowledgement of complete response and is granted Class 2 review Thursday December 6, 5:09 pm ET
ECUBLENS, Switzerland, Dec. 6 /PRNewswire-FirstCall/ - Neurochem (International) Limited (Neurochem), a wholly-owned subsidiary of Neurochem Inc. (NASDAQ: NRMX - News; TSX: NRM - News), announces that the Company has received an acknowledgement from the United States Food and Drug Administration (FDA) that Neurochem's response to the July 2007 approvable letter for the New Drug Application (NDA) for eprodisate (KIACTA(TM)) for the treatment of Amyloid A (AA) amyloidosis is a complete, Class 2 response. The PDUFA (Prescription Drug User Fee Act) goal date by which the FDA is expected to render a decision is April 2, 2008.
The NDA for approval of eprodisate (KIACTA(TM)) for the treatment of AA amyloidosis was filed in February 2006. The Company submitted its response to the second approvable letter last September and this response has been acknowledged as complete by the FDA, allowing for the Class 2 review.
"We look forward to further productive interactions with the FDA as we enter late-stage discussions on our marketing application," said Dr. Francesco Bellini, Neurochem Inc.'s Chairman, President and CEO.
About eprodisate (KIACTA(TM))
Eprodisate (KIACTA(TM)) was investigated in an international, randomized, double-blind, placebo-controlled, and parallel-designed Phase II/III clinical trial in which 183 AA amyloidosis patients were enrolled at 27 sites around the world (Eprodisate for AA Amyloidosis Trial, EFAAT). Patients who completed the clinical trial were eligible for enrollment in an ongoing open-label extension study, some of whom have now been receiving eprodisate (KIACTA(TM)) for more than six years.
In September 2006, the European Medicines Agency (EMEA) confirmed that it had commenced a regulatory review of eprodisate (KIACTA(TM)). The Marketing Authorization Application is being reviewed under the Agency's centralized procedure. This means that an authorization from this Agency would apply to all 27 European Union member states, as well as to Norway and Iceland. An oral hearing occurred with the EMEA in November 2007 to discuss outstanding issues raised with respect to the eprodisate (KIACTA(TM)) application and a decision from the EMEA is expected by year-end, or shortly thereafter.
The Company also filed for marketing approval for eprodisate (KIACTA(TM)) for the treatment of AA amyloidosis in Switzerland. A decision is expected in 2008.
Eprodisate (KIACTA(TM)) has received orphan drug status in the United States, the European Union and in Switzerland.
Neurochem Inc. sponsored the EFAAT study.
About Amyloid A (AA) Amyloidosis
A progressive and fatal condition, AA amyloidosis occurs in a proportion of patients with chronic inflammatory disorders, chronic infections and inherited diseases such as familial Mediterranean fever. The kidney is the organ most frequently affected and progression to dialysis/end-stage renal disease is the most common clinical manifestation in this disease. Currently, there is no approved therapy to treat AA amyloidosis and about half of all patients diagnosed with the disease die within five years of diagnosis.
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