Neurochem International Ltd, of Lausanne, Switzerland, announced that its new drug application (NDA) for eprodisate (1,3-propanedisulfonate, Fibrillexâ„¢) for the treatment of Amyloid A (AA) amyloidosis has been granted priority review by the US Food and Drug Administration (FDA), with a decision on the approvability of the drug expected by August 13, 2006. The FDA grants priority review to product candidates that would offer a significant improvement in the treatment, diagnosis, or prevention of a disease or that address an unmet medical need.

AA amyloidosis is a progressive and fatal condition that occurs in a proportion of patients with chronic inflammatory disorders, including rheumatoid arthritis and Crohn's disease, 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. Patients suffering from AA amyloidosis have a poor prognosis, with 5- to 15-year survival rates of 50% and 25%, respectively. Analysis of the clinical data from a phase II/III clinical trial for eprodisate indicated that the drug reduced the risk of renal decline or all-cause mortality to 42% relative to placebo (P = .025).
 
Fibrillex has received Orphan Drug Designation status in the US and Orphan Medicinal Product designation in Europe (the US normally provides a drug with 7 years and Europe with 10 years of market exclusivity upon regulatory approval). Fibrillex is also a Fast Track product candidate and part of the FDA's Continuous Marketing Application Pilot 1 and Pilot 2 programs.

Neurochem has granted Centocor, Inc, of Malvern, Pennsylvania, exclusive distribution rights for Fibrillex worldwide, with the exception of Canada, Switzerland, Japan, China, South Korea, and Taiwan.

— A. Techman