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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.

Due to the lack of clear endpoints, sponsors have been waiting to advance non-alcoholic steatohepatitis (NASH) candidates into pivotal trials. But with an agreement with FDA on the horizon, the leading candidate should have a Phase III protocol in place in the next few months.

NASH is seen as a coming epidemic of liver disease, presenting a host of serious issues and co-morbidities arising from...

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