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FDA grants fast track for Shire’s NASH investigational treatment
29 July 2016 • Author: Mandy Parrett, Editorial Assistant
Shire Plc has announced today that the United States Food and Drug Administration (FDA) has granted Fast Track designation for SHP626 (volixibat) for an investigational treatment of adults with nonalcoholic steatohepatitis (NASH) with liver fibrosis.
Global biotechnology company, Shire, is developing SHP626 as a once daily, orally-administered inhibitor of the apical sodium dependent bile acid transporter (ASBT) – a protein that is primarily responsible for recycling bile acids from the intestine to the liver. NASH is a serious, chronic liver disease that can be severe and lead to fibrosis, cirrhosis, liver failure and liver cancer. 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.”
Promising preliminary results for NASH
side effects assessed
Additional information on the SHP626 Phase 2 study can be found on clinicaltrials.gov:
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