Infographic: A Snapshot Of Non-Alcoholic Steatohepatitis R&D
Madrigal may gain the first NASH approval in early 2024; numerous candidates are lining up behind.
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.
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Inventiva’s pan-PPAR agonist and Terns’ combination strategy are targeting the NASH treatment paradigm after expected approval of Madrigal’s resmetirom. Viking is hoping to prove a better THRβ drug profile than Madrigal.
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.
EMA Considers Accelerated Review Of Madrigal’s NASH Drug Filing, Discloses Other Fast-Track Decisions
Resmetirom, for noncirrhotic non-alcoholic steatohepatitis, is among the investigational products that the European Medicines Agency has been considering for review under its accelerated assessment pathway.