CHMP Issues Negative Opinion for Kiacta Indication

Swiss drugmaker Neurochem received a negative opinion from the Committee for Medicinal Products for Human Use (CHMP) on its marketing application for Kiacta as a treatment for Amylois A amyloidosis.

The committee concluded the company needed to conduct another study to demonstrate Kiacta’s (eprodisate) effectiveness. 

Neurochem may request a re-examination from CHMP within 15 days of receipt of the opinion.

The company also received FDA acknowledgement that its response to a July approvable letter for the new drug application for Kiacta is a complete, Class 2 response. The Prescription Drug User Fee Act goal date is April 2, 2008, Neurochem said.