Neurochem (International) Limited, a wholly-owned subsidiary of Neurochem Inc. filed the new drug application (NDA) for eprodisate (Fibrillex) for the treatment of Amyloid A (AA) amyloidosis and granted priority review by the US FDA.
The FDA priority review designation establishes a target six-month review period from the date of receipt of the eprodisate (Fibrillex) NDA. The PDUFA (Prescription Drug User Fee Act) goal date, when the FDA is expected to render a decision on the approvability of eprodisate (Fibrillex), is August 13, 2006.
In a Phase II/III clinical trial, eprodisate (Fibrillex) was investigated to evaluate its safety and efficacy in patients with AA amyloidosis, a disease that is believed to affect close to 17,000 people in the US. Currently, there is no FDA-approved therapy to treat AA amyloidosis, a condition that normally progresses to end-stage renal disease (ESRD), dialysis and ultimately death.
"This priority review acknowledges the need for a new medicine, potentially Fibrillex, to provide a therapeutic solution for this serious illness," Denis Garceau, Neurochem's Senior Vice President, Drug Development said adding, "We look forward to continuing to work closely with the FDA as it reviews the NDA."
Over the course of its development, eprodisate (Fibrillex) received Orphan Drug Designation and Fast Track status by the FDA, and was accepted by the Agency for the Continuous Marketing Application (CMA) Pilot 1 and 2 programs.
In December 2004, Neurochem signed a definitive collaboration and distribution agreement, granting Centocor, Inc., of Malvern, Pennsylvania, USA, a wholly owned subsidiary of Johnson & Johnson, exclusive distribution rights for eprodisate (Fibrillex) worldwide, with the exception of Canada, Switzerland, Japan, China, South Korea and Taiwan.