Neurochem Fibrillex NDA
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Neurochem completes rolling NDA submission for its orphan drug Fibrillex (eprodisate), the firm announces Feb. 13. The company is seeking an indication for amyloid A amyloidosis. "There is currently no treatment directed specifically at [the disease]," Neurochem says. The firm initiated the submission for the glycosaminoglycan mimetic in August 2005; the agent is part of FDA's continuous marketing application Pilot 1 and Pilot 2 programs (1Pharmaceutical Approvals Monthly September 2005, In Brief)...