NEUROCHEM SUBMITS NDA FOR FIBRILLEX

Neurochem Limited has submitted to the FDA the final modules of its new drug application (NDA) for eprodisate (Fibrillex). The company is seeking marketing approval of its investigational product candidate Fibrillex for the treatment of amyloid A (AA) amyloidosis.

AA amyloidosis is a progressive and fatal condition that occurs in a proportion of patients with chronic inflammatory disorders, chronic infections and inherited diseases such as familial mediterranean fever. The kidney is the organ most frequently affected by AA amyloidosis, and progression to dialysis and end stage renal disease is the most common cause of death in this disease. New approaches to treatment for AA amyloidosis are urgently needed due to lack of specific therapies.