Amyloid A Amyloidosis

New drug application initiated for Fibrillex

Published in Medical Letter on the CDC and FDA, September 25th, 2005

Neurochem (International) Limited (Neurochem), a wholly-owned subsidiary of Neurochem Inc. (NRMX; NRM), announced that it has initiated, under the continuous marketing application (CMA) pilot 1 program, the submission of a "rolling" new drug application (NDA) to the U.S. Food and Drug Administration (FDA) seeking marketing approval for its investigational product candidate, Fibrillex.

Fibrillex is for the treatment of Amyloid A (AA) Amyloidosis. Neurochem plans to complete the submission of the NDA at or around year-end. As announced earlier, the FDA has agreed to file and review this NDA. AA Amyloidosis is a serious medical condition for which no specific treatment...

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Source: Medical Letter on the CDC and FDA (2005-09-25)

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