'Clean Label' For Intercept's Ocaliva In PBC Bodes Well For NASH Claim
Executive Summary
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.
You may also be interested in...
Terns Raises $87m More For NASH R&D, Including Lilly Equity Purchase
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.
CymaBay Focused On PBC With Seladelpar, Wants Partner For NASH
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.
Intercept Unlikely To Refile OCA For NASH Before Late 2021
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.