KiactaTreatment for Amyloid A Amyloidosis
Neurochem's Eprodisate (Kiacta) PDUFA Date Extended Three Months by FDA
ECUBLENS, Switzerland, April 11, 2007 /PRNewswire-FirstCall/ - Neurochem (International) Limited (Neurochem), a wholly owned subsidiary of Neurochem Inc. , announces that it received notification from the United States Food and Drug Administration (FDA) that the action date for FDA's review of the New Drug Application (NDA) for eprodisate (Kiacta) for the treatment of Amyloid A (AA) amyloidosis, has been extended to July 16, 2007. Previously, the action date under the Prescription Drug User Fee Act (PDUFA) for the eprodisate (Kiacta) NDA was April 16, 2007.
The FDA is extending the PDUFA goal date by three months to provide time for a full review of an amendment to the eprodisate (Kiacta)) NDA submitted by Neurochem Inc. in February 2007. This additional submission is considered by the FDA to be a major amendment to the NDA, allowing an extension of the action date.
Eprodisate (Kiacta) was investigated in a landmark international, randomized, double-blind, placebo-controlled, and parallel-designed 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) for more than five years. Eprodisate (Kiacta) has received orphan drug status in the United States, the European Union and in Switzerland.
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.
The EFATT study was sponsored by Neurochem Inc.
Neurochem Inc. is focused on the development and commercialization of innovative therapeutics to address critical unmet medical needs. Eprodisate (Kiacta) - formerly FIBRILLEX is currently being developed for the treatment of Amyloid A (AA) amyloidosis, and is under regulatory review for marketing approval by the United States Food and Drug Administration and European Medicines Agency. Tramiprosate (ALZHEMED), for the treatment of Alzheimer's disease, has completed a Phase III clinical trial in North America and is currently in a Phase III clinical trial in Europe, while tramiprosate (CEREBRIL), for the prevention of Hemorrhagic Stroke caused by Cerebral Amyloid Angiopathy, has completed a Phase IIa clinical trial.
This news release contains forward-looking statements regarding eprodisate (Kiacta), as well as regarding continuing and further development efforts. These statements are based on the current analysis and expectations of management. Drug development necessarily involves numerous risks and uncertainties, which could cause actual results to differ materially from this current analysis and these expectations. Analysis regarding the results of clinical trials may not provide definitive results regarding safety, tolerability or therapeutic benefits. There is no certainty that regulators will ultimately approve eprodisate (Kiacta) for sale to the public. Risks and uncertainties may include: failure to demonstrate the safety, tolerability and efficacy of our product, that actual results may vary once the final and quality-controlled verification of data and analyses has been completed, the expense and uncertainty of obtaining regulatory approval, including from the FDA, and the possibility of having to conduct additional clinical trials. Further, even if regulatory approval is obtained, therapeutic products are generally subject to: stringent on-going governmental regulation, challenges in gaining market acceptance, and competition. Neither Neurochem Inc., nor Neurochem (International) Limited undertake any obligation to publicly update any forward-looking statements, whether as a result of new information, future events, or otherwise. Please see Neurochem Inc.'s Annual Information Form for further risk factors that might affect Neurochem Inc., Neurochem (International) Limited and their respective businesses.
Posted: April 2007
- 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 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 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