KiactaTreatment for Amyloid A Amyloidosis
Neurochem Submits NDA for Fibrillex
ECUBLENS, Switzerland, February 13, 2006 - Neurochem (International) Limited (Neurochem), a wholly-owned subsidiary of Neurochem Inc. , announces today that the Company has submitted to the U.S. Food and Drug Administration (FDA) the final modules of its new drug application (NDA) for eprodisate (Fibrillex). The Company is seeking marketing approval of its investigational product candidate Fibrillex for the treatment of Amyloid A (AA) amyloidosis. The submission announced today completes this "rolling" NDA that was initiated last August, under the Continuous Marketing Application (CMA) Pilot 1 program. The FDA agreed in June 2005 to file and review the NDA.
AA amyloidosis is a progressive and fatal condition that 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 by AA amyloidosis, and progression to dialysis and end stage renal disease is the most common cause of death in this disease. New approaches to treatment for AA amyloidosis are urgently needed due to lack of specific therapies. Fibrillex has received Orphan Drug Designation status in the United States as it is estimated that there are about 20,000 patients in North America.
"Completion of this application to the FDA for Fibrillex marks a very important milestone in Neurochem's progression towards its mission of bringing novel and innovative drugs to market thereby addressing serious and unmet medical needs," said Dr. Francesco Bellini, Chairman, President and Chief Executive Officer. "We believe that the NDA package supports the clinically and statistically meaningful effect of this product candidate on the preservation of kidney function in this patient population and its benign safety profile," he added.
"Effective treatment for AA amyloidosis is an important unmet medical need," said Laura M. Dember, M.D., Nephrologist and Associate Professor of Medicine at School of Medicine. Dr. Dember was a principal investigator for Neurochem's Phase II/III clinical trial. "Patients with this disease often progress to end-stage renal failure, and many die. There is currently no treatment directed specifically at AA amyloidosis. This drug has the potential to provide a much needed therapeutic solution for this devastating illness."
About the Phase II/III clinical trial
The Phase II/III clinical trial for Fibrillex was a two-year, international, multi-center, randomized, double-blind, placebo-controlled, and parallel-designed trial to evaluate the safety and efficacy of Fibrillex in patients suffering from AA amyloidosis. Neurochem enrolled 183 patients for this trial, which was conducted at 27 sites located across North America, Europe and Israel.
Neurochem has an exclusive collaboration and distribution agreement for Fibrillex with Centocor, Inc.
Posted: February 2006
- Neurochem Moves Eprodisate (Kiacta) Drug Development Program Forward for Amyloid A Amyloidosis - March 13, 2008
- Neurochem Announces Eprodisate (Kiacta) Receives Acknowledgement of Complete Response and is Granted Class 2 Review - December 7, 2007
- Neurochem Receives Approvable Letter for Eprodisate (Kiacta) for Treatment of AA Amyloidosis - July 18, 2007
- Neurochem's Eprodisate (Kiacta) PDUFA Date Extended Three Months by FDA - April 11, 2007
- Neurochem submits a complete response to FDA approvable letter for Kiacta - October 16, 2006
- Neurochem Receives Approvable Letter for Eprodisate (Kiacta) for Treatment of AA Amyloidosis - August 11, 2006
- Neurochem Announces Fibrillex NDA Filed and Granted Priority Review - April 18, 2006
- Neurochem Initiates Submission of NDA for Fibrillex - August 22, 2005
- FDA Agrees to File and Review NDA for Fibrillex - June 30, 2005