29 July 2016 - Shire today announced that the United States FDA has granted fast track designation for SHP626 (volixibat) for an investigational treatment of adults who have non-alcoholic steatohepatitis with liver fibrosis.

Shire is developing SHP626 as a once daily, orally-administered inhibitor of the apical sodium dependent bile acid transporter (ASBT), a protein which is primarily responsible for recycling bile acids from the intestine to the liver. Non-alcoholic steatohepatitis (NASH) is a serious, chronic liver disease for which there are currently no approved drugs.

"Shire’s development plan for SHP626 is designed to address the unmet need in the treatment of adult patients who have NASH with liver fibrosis,” said Philip J. Vickers, Ph.D., Head of R&D, Shire. "This fast track designation is further recognition of the critical need to develop new, effective therapeutic options for patients with this serious condition." The FDA fast track designation for SHP626 in NASH was supported by preclinical and Phase 1 studies. The FDA’s Fast Track is a process designed to facilitate the development, and expedite the review of drugs to treat serious conditions and fill an unmet medical need. However, it does not guarantee that the FDA will ultimately approve SHP626 for NASH or the timing of any such approval.

Read Shire press release