Akero First To Show Benefit In Cirrhotic NASH Patients
Although the data are from a small cohort of an ongoing study, Akero’s FGF21 analog reduces fibrosis score by at least one stage in 33% of cirrhotic NASH patients.
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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.
Follow-up Phase IIa data shows strong antifibrotic and NASH-resolution effects for Akero’s efruxifermin, an FGF21 analog. Analysts are calling the drug potentially best in class.
Akero’s FGF21 analog yields 63%-72% relative hepatic fat reduction in Phase IIa study; the company awaits biopsy data hoping to see a fibrotic benefit. Also, Genfit says COVID-19 pandemic should not significantly delay its Phase III NASH readout.