Madrigal Shows Confidence As It Awaits FDA’s March Decision On Resmetirom

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.

2023 AASLD
At AASLD in Boston, it seemed fair to view Madrigal as the “belle of the ball.” • Source: Scrip

Although still a clinical-stage biopharma company, Madrigal Pharmaceuticals, Inc. made an all-out showing at the American Association for the Study of Liver Disease annual meeting to establish its position as the leader in the NASH race – from sponsoring the wi-fi at the meeting and emblazoning its logo on many attendees’ hotel key cards to introducing a new chief commercialization officer and launching physician awareness efforts.

Madrigal has a 14 March US Food and Drug Administration action date for resmetirom (MDGL-3196), its thyroid hormone receptor beta (THRβ) agonist up for approval to treat non-alcoholic steatohepatitis (NASH) with advanced fibrosis

Key Takeaways
  • Madrigal presented an air of confidence at 2023’s Liver Meeting that resmetirom is likely to be the first approved NASH drug, and used the conference to make a splash before prescribers.

  • The THRβ agonist has a March FDA action date and could become an approved therapy to treat NASH patients with advanced fibrosis after Intercept was expected to reach market first in 2020

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