Skip to Content

Kiacta Approval Status

  • FDA approved: No
  • Brand name: Kiacta
  • Generic name: eprodisate
  • Previous name: Fibrillex
  • Company: Neurochem
  • Treatment for: Amyloid A Amyloidosis

Kiacta (eprodisate) is an investigational glycosaminoglycan mimetic intended for use in the treatment of Amyloid A Amyloidosis.

In July 2007, Neurochem announced the receipt of an Approvable Letter from the U.S. Food and Drug Administration (FDA) advising the company that the New Drug Application (NDA) for Kiacta was approvable pending an additional efficacy trial.

Development Status and FDA Approval Process for Kiacta

Mar 13, 2008Neurochem Moves Eprodisate (Kiacta) Drug Development Program Forward for Amyloid A Amyloidosis
Dec  7, 2007Neurochem Announces Eprodisate (Kiacta) Receives Acknowledgement of Complete Response and is Granted Class 2 Review
Jul 18, 2007Neurochem Receives Approvable Letter for Eprodisate (Kiacta) for Treatment of AA Amyloidosis
Apr 11, 2007Neurochem's Eprodisate (Kiacta) PDUFA Date Extended Three Months by FDA
Oct 16, 2006Neurochem submits a complete response to FDA approvable letter for Kiacta
Aug 11, 2006Neurochem Receives Approvable Letter for Eprodisate (Kiacta) for Treatment of AA Amyloidosis
Apr 18, 2006Neurochem Announces Fibrillex NDA Filed and Granted Priority Review
Feb 13, 2006Neurochem Submits NDA for Fibrillex
Aug 22, 2005Neurochem Initiates Submission of NDA for Fibrillex
Jun 30, 2005FDA Agrees to File and Review NDA for Fibrillex

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.