NASH Drugs Soon May Have A Registrational Pathway, Finally
Numerous companies vie to become first to market with a therapy for the unmet medical need, which can lead to fibrosis, cirrhosis and need for a liver transplant. FDA may allow surrogate endpoints in pivotal trials to speed up approval of initial NASH therapies.
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Genfit Thinks Intercept’s Lead In NASH Not As Wide As Perceived
Genfit believes elafibranor’s clean tolerability and safety profile may help narrow the gap between it and Intercept’s OCA, with safety questions delaying OCA’s entry to market. Part two of Scrip’s interview with Genfit’s CEO and COO.
Intercept's Revised NASH Trial Improves Prospects
The pivotal REGENERATE study of Ocaliva now can succeed if either of two co-primary endpoints is achieved. Intercept also will use a new "objective" definition of NASH resolution in the study.
Galectin Hopes To Set Surrogate Endpoints For NASH Cirrhosis, Despite Trial Failure
Failure of small NASH cirrhosis study does not present much read-through to the larger class of NASH drugs in development. Galectin hopes its ongoing Phase IIb trial will validate its galectin-3 inhibitor in a more advanced disease state than most NASH candidates are pursuing.