No Read-Through Expected: NASH Field Unfazed By Intercept’s FDA Rejection
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.
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Analysts say the cirrhosis-reversing benefit seen with Akero’s efruxifermin portends well for the entire class, and that 89bio might differentiate on safety, tolerability and dosing frequency.
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.
Intercept and Axcella provide updated data on their NASH programs at the International Liver Conference, while CymaBay offers the full dataset for seladelpar in PBC.