Neurochem Fibrillex misses endpoint
This article was originally published in Pharmaceutical Approvals Monthly
Neurochem's amyloid A amyloidosis agent Fibrillex fails to meet its primary endpoint in a Phase II/III trial, the firm says April 18. Preliminary results from the two-year, 183-patient study found there were 13.4% more patients on Fibrillex than placebo who remained stable or improved (p=0.06). The primary endpoint required a 20% absolute difference in the number of stabilized/improved patients versus placebo (p<0.01). Neurochem, which previously projected a 2005 NDA submission, says it remains committed to Fibrillex and will discuss its complete Phase II/III findings with FDA. Fibrillex was accepted into FDA's continuous marketing application Pilot 2 program by the cardio-renal division in July 2004 (1Pharmaceutical Approvals Monthly December 2004, p. 17)...
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