Home » CHMP Issues Negative Opinion for Kiacta Indication
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.
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