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FDA fast tracks Shire’s SHP626 nonalcoholic steatohepatitis drug

Published on 29/07/16 at 12:37pm

The Food and Drug Administration (FDA) has granted Fast Track designation to Shire’s SHP626 (volixibat) treatment for patients suffering from non-alcoholic steatohepatitis (NASH) with liver fibrosis.

The FDA’s Fast Track process is designed to facilitate the development and review of drugs to treat conditions which inflict serious adverse effects or for which there is an unmet medical need, though it does not guarantee approval. The body’s decision was based on SHP626’s supportive preclinical and Phase II studies.

NASH is a type of nonalcoholic fatty liver disease (NAFLD) causing inflammation and the accumulation of fat in the liver, for which there are currently no approved drugs. SHP626 is being developed 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.

"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,” commented Philip J. Vickers, head of R&D at Shire. "This Fast Track designation is further recognition of the critical need to develop new, effective therapeutic options for patients with this serious condition."

Matt Fellows

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