FDA Extends Review of Neurochem Kiacta Application

Neurochem announced it has received notification from the FDA that the action date for the agency's review of the new drug application (NDA) for Kiacta has been rescheduled from April 16 to July 16.

Kiacta (eprodisate) is intended for the treatment of Amyloid A (AA) amyloidosis. There is currently no treatment for the deadly disease, which often destroys kidney function, according to the company.

Neurochem said the FDA is extending the date by three months to provide time for a full review of an amendment to the NDA submitted in February. The submission is considered by the FDA to be a major amendment to the NDA.

In August 2006 company had received an approvable letter for Kiacta in which the FDA requested additional efficacy information, as well as a safety update. The company submitted a response in October.

Neurochem investigated Kiacta in a randomized, double-blind, placebo-controlled, parallel-designed trial in which 183 AA amyloidosis patients were enrolled at 27 sites around the world. Patients who completed the clinical trial were eligible for enrollment in an ongoing open-label extension study, some of whom have now been receiving Kiacta for more than five years. The drug has received orphan status in the U.S., the European Union and Switzerland.