Genfit Delays NASH Data While It Confers With US FDA On Methodology
Genfit will delay unblinding of data from its nearly complete Phase III study of elafibranor to get insight from the FDA on statistical methods in order to optimize its NDA.
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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.
Cadila Healthcare has received the first approval globally, in India, for a NASH therapy, after the national regulator cleared its candidate saroglitazar. The company also expects to begin Phase III trials in the US in the second quarter of fiscal 2021.
Intercept hopes to be first to market in NASH with an indication to treat fibrosis. It also is enrolling a study to show a benefit in NASH patients with cirrhosis.