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)...
You may also be interested in...
Neurochem Fibrillex gets priority
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...
Neurochem Fibrillex NDA gets rolling
Neurochem plans to complete its rolling NDA for Fibrillex (glycosaminoglycan mimetic) by year-end after announcing submission of the first unit of the application Aug. 22 for treatment of amyloid A amyloidosis. In April, Neurochem announced results from a Phase II/III trial in which Fibrillex missed its primary endpoint and said it would discuss the results with FDA. Fibrillex is part of FDA's continuous marketing application Pilot 1 and Pilot 2 programs...
Keeping Track: Cancer Approvals From Lumisight Imaging To Adjuvant Alecensa
The US FDA’s approval of Lumicell’s optical imaging agent Lumisight makes a dozen novel approvals in 2024 for the Center for Drug Evaluation and Research.