FDA Accepts Axcan NDA For Ursodiol As PBC Therapy

Canadian firm Axcan Pharma says its New Drug Application for URSO (ursodeoxycholic acid; UDCA) in the treatment of primary biliary cirrhosis has been accepted for filing by the US Food and Drug Administration. Data will be presented to the FDA's gastrointestinal expert advisory committee on November 6-7. Because of its existing orphan drug status, fast-tracking of URSO by the agency is expected.

Axcan has also filed an Investigational NDA submission related to the use of UDCA 750mg or 1.5g/day as URSO 250mg tablets to delay the recurrence of metachronous adenomatous colorectal polyps. The company also plans to embark on a clinical research program on the efficacy and safety of URSO in the treatment of hypercholesterolemia.