KiactaTreatment for Amyloid A Amyloidosis
Neurochem Receives Approvable Letter for Eprodisate (Kiacta) for Treatment of AA Amyloidosis
Neurochem Will Host a Conference Call on August 14, 2006, at 8:30 A.M. ET
LAVAL, Quebec, August 11, 2006 -- Neurochem Inc. announces that it has received an approvable letter from the U.S. Food and Drug Administration (FDA) for eprodisate (Kiacta - formerly Fibrillex) for the treatment of Amyloid A (AA) amyloidosis.
In its action letter, the FDA requested additional efficacy information, as well as a safety update. The FDA stated that this efficacy information would probably need to be addressed by one or more additional clinical trials. As an alternative, the FDA also stated that significant findings obtained from a complete follow-up of patients in the existing study could be persuasive. The FDA asked for further manufacturing and pharmacokinetic information, and acknowledged that a QT clinical study should be submitted as part of a Phase 4 (post approval) commitment.
"We are pleased with the FDA's response and the constructive relationship we have with them," said Dr. Francesco Bellini, Chairman, President and CEO of Neurochem. "We are working closely with the agency to secure as soon as possible the final approval without conducting a new efficacy clinical trial. We are already starting to collect additional information as suggested by the FDA," he concluded.
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 and end stage renal disease is the most common cause of death in this disease. Currently, there is no FDA-approved therapy to treat AA amyloidosis and half of all patients diagnosed with the disease die within five years of diagnosis.
Kiacta underwent a landmark international, randomized, double-blind, placebo-controlled, and parallel-designed clinical trial in which 183 patients were enrolled in 27 sites around the world.
In April 2006, the FDA granted Priority Review to Kiacta, a classification reserved for product candidates that would offer a significant improvement in the treatment, diagnosis or prevention of a disease or that address an unmet medical need. Over the course of its development, Kiacta 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.
Neurochem will host a conference call at 08H30 Eastern Time, Monday, August 14, 2006.
To participate in the conference call, please dial the following numbers approximately 10 minutes prior to the start of the call: 416-644-3430 or 1-800-814-4861. A replay of the conference call will be available for one week (until August 21, 2006), commencing one hour after the end of the call. The instant replay numbers are 416-640-1917 or 1-877-289-8525. The access code for the replay is 21200044. Please mention that you are calling for the Neurochem conference replay.
Posted: August 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 Announces Fibrillex NDA Filed and Granted Priority Review - April 18, 2006
- Neurochem Submits NDA for Fibrillex - February 13, 2006
- Neurochem Initiates Submission of NDA for Fibrillex - August 22, 2005
- FDA Agrees to File and Review NDA for Fibrillex - June 30, 2005