Resmetirom: First Approval

May 21, 2024Drugs

Resmetirom: First Official Approval

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Abstract

In March 2024, resmetirom received accelerated approval for treating adults with moderate to advanced liver fibrosis associated with noncirrhotic NASH in the USA.

Resmetirom is an oral medication that acts as an agonist for the thyroid hormone receptor-β.
The drug is aimed at addressing metabolic dysfunction linked to steatohepatitis.
Approval was granted for use alongside diet and exercise in specific patient populations.
Resmetirom is also undergoing regulatory review in the European Union for the same condition.
The article outlines key milestones in the development of resmetirom leading to its approval.

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Resmetirom (Rezdiffra™) is an oral thyroid hormone receptor-β (THR-β) agonist being developed by Madrigal Pharmaceuticals, Inc., to target the key underlying causes of metabolic dysfunction associated steatohepatitis (MASH) [previously known as nonalcoholic steatohepatitis (NASH)]. In March 2024, resmetirom was approved for use (under accelerated approval) in conjunction with diet and exercise for the treatment of adults with noncirrhotic NASH with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis) in the USA. Resmetirom is also under regulatory review in the EU for the treatment of MASH/NASH. This article summarizes the milestones in the development of resmetirom leading to this first approval for the treatment of adults with MASH/NASH.

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Resmetirom: First Approval

Abstract

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