NEUROCHEM FILES NDA FOR EPRODISATE

Neurochem International's new drug application (NDA) for eprodisate (Fibrillex) for the treatment of amyloid A (AA) amyloidosis has been filed and granted priority review by the FDA.

In a Phase II/III clinical trial, eprodisate was investigated to evaluate its safety and efficacy in patients with AA amyloidosis, a disease that is believed to affect close to 17,000 people in the U.S. Currently, there is no FDA-approved therapy to treat AA amyloidosis, a condition that normally progresses to end-stage renal disease.