Intercept, Madrigal Get Ready For NASH Commercialization
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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With a 14 March FDA action date and no advisory panel scheduled, Madrigal is looking ahead to resmetirom becoming the first approved NASH therapy, following stumbles by competitors.
After a multi-year lull, NASH R&D has picked up this past year with key data readouts, several programs advancing toward Phase III and Madrigal's resmetirom under FDA review with a March 2024 action. This graphic provides a look at the overall status of NASH drug R&D.
While Intercept is calling it quits in NASH with its FXR agonist obeticholic acid following a second complete response letter, other companies are staying the course with Phase II molecules in the class.