Neurochem submits Fibrillex NDA to FDA

Canadian biopharmaceutical company Neurochem says that it has filed a New Drug Application relating to its drug Fibrillex (eprodisate) with the US Food and Drug Administration. The compound, which is intended for the treatment of amyloid A amyloidosis, a progressive fatal condition associated with chronic inflammatory disorders or infection, has also been granted priority review status.

The NDA is based on data from a randomized, double-blind, placebo-controlled Phase II/III clinical trial of the compound, which was completed in 2004. Analysis of the results showed that the drug reduced the risk of renal decline and all-cause mortality by 42% in comparison with placebo. The firm added that it expects the FDA to announce its decision on August 13 this year.