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Neurochem Fibrillex gets priority

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Neurochem's amyloid A amyloidosis treatment Fibrillex (eprodisate) has a priority review user fee date of August 13, the firm announces April 18. The rolling NDA for the orphan drug was completed Feb. 13 (1Pharmaceutical Approvals Monthly March 2006, In Brief). The application includes a Phase II/III trial that found 13.4% fewer patients worsened in the Fibrillex group compared to placebo. Neurochem estimates 17,000 people in the U.S. have AA amyloidosis; the disease usually progresses to end-stage renal disease. Fibrillex, a glycosaminoglycan mimetic, would be the first agent approved for the condition...

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