Intercept, Madrigal Get Ready For NASH Commercialization

 
• By Joseph Haas

With a 22 June US FDA action date for obeticholic acid in non-alcoholic steatohepatitis, Intercept is thinking ahead to launch plans. Madrigal said it plans a Q2 filing for its NASH drug and hopes to find an ex-US commercial partner.

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Intercept, Madrigal may be heading toward approval in NASH

Intercept Pharmaceuticals, Inc. is getting ready once again – after a roughly three-year interruption – for commercialization of potentially the first approved non-alcoholic steatohepatitis (NASH) drug, as the user fee date for obeticholic acid (OCA) approaches. The company expects a US Food and Drug Administration advisory committee review of its new drug application a few weeks before the 22 June action date and told shareholders on 2 March that it thinks marketing of OCA in primary biliary cholangitis (PBC) will give it a head start on reaching the right clinicians in NASH.

Meanwhile, the other company with near-term likelihood of bringing a NASH drug to market in the US, Madrigal Pharmaceuticals,...

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