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NASH: Update Bulletin [November 2017]

Product Code:
Publication Date:
November 2017

This edition presents key opinion leader (KOL) views on the latest events that have the potential to shape the treatment landscape of nonalcoholic steatohepatitis (NASH). Topics covered include expert opinions on the recent FDA safety warnings for Intercept Pharmaceuticals’ Ocaliva (obeticholic acid) in patients with primary biliary cirrhosis (PBC) and how this will impact the drug’s prospects in NASH. KOLs weighed up the two-year data published for the CENTAUR study with Allergan’s cenicriviroc,  and also provide their opinions on Phase II study data presented at the annual Liver Meeting in October 2017 for Gilead’s GS-0976, an oral inhibitor of Acetyl-CoA carboxylase (ACC), in patients with NASH.

Business Questions:

• How do KOLs view the FDA safety warnings for Intercept’s Ocaliva in PBC and what can be done to alleviate any concerns?
• How will the FDA warnings impact obeticholic acid’s future prospects in NASH?
• What are KOL opinions on results published from the CONTROL study investigating obeticholic acid with concurrent statin administration?
• Do KOLs anticipate any amendments to obeticholic acid’s label such as a boxed warning or instructions to co-prescribe statins?
• What are the experts’ initial thoughts on the top-line two-year data published for Allergan’s cenicriviroc in the Phase IIb CENTAUR study?
• Will the two-year data from CENTAUR impact KOL expectations for the ongoing Phase III AURORA study with cenicriviroc?
• How do KOLs view the Phase II data for Gilead’s GS-0976 presented at the annual Liver Meeting in October 2017?
• Is a reduction in hepatic fat enough to secure approval as a monotherapy in NASH or can GS-0976 be paired with anti-fibrotic or anti-inflammatory agents?
• What sort of role do experts envisage for GS-0976 in the NASH treatment space or is it too early to speculate?


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