'Clean Label' For Intercept's Ocaliva In PBC Bodes Well For NASH Claim
By determining a safe dosing regimen for Child-Pugh B and C patients, FDA was able to provide a label almost completely without contraindications despite safety concerns about liver-related adverse reactions.
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In its third venture funding round, Terns adds backing from Deerfield in addition to Lilly’s investment. It licensed three non-alcoholic steatohepatitis candidates from the big pharma in 2018.
With an FDA clinical hold lifted, CymaBay plans to initiate a new Phase III in primary biliary cholangitis early in 2021. It also hopes to partner the drug in NASH with a company developing a metabolic drug for the disease.
Once determined to resubmit its NDA by the end of 2020, Intercept now says talks with the FDA have presented a new path to approval in non-alcoholic steatohepatitis that could mean refiling sometime in 2021.