Fibrillex on fast track to ’05 filing
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Neurochem hopes to complete Phase II/III clinical trial for its fast-track drug candidate Fibrillex by January 2005, with a subsequent 2005 NDA submission. The two-year, randomized, double-blind, placebo-controlled, parallel-design study in secondary amyloid A amyloidosis is ongoing. Fibrillex is a glycosaminoglycan mimetic that treats AA amyloidosis by preventing amyloid fibril formation...