Madrigal Cements Case For Hepatic Fat Reduction, Other NASH Benefits With MGL-3196
Madrigal’s selective THR beta agonist continues to demonstrate hepatic fat-lowering abilities in 36-week data, along with lipid-lowering characteristics. The company hopes to initiate a Phase III study in early 2019.
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With still no approved therapy for non-alcoholic steatohepatitis, Intercept, Madrigal, Inventiva and others used the liver meeting to build the cases for their NASH candidates.
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.
Execs from Madrigal, Cirius and Axcella say the FDA’s complete response letter is specific to shortcomings of Intercept’s OCA – and leaves the race to be first to market wide open again.