FDA Approves First Treatment for Patients with Liver Scarring Due …
Today, the U.S. Food and Drug Administration approved Rezdiffra (resmetirom) for the treatment of adults with noncirrhotic non-alcoholic steatohepatitis (NASH) with moderate to advanced liver...
Rezdiffra (resmetirom) FDA Approval History - Drugs.com
Mar 19, 2024 · Rezdiffra FDA Approval History. Last updated by Judith Stewart, BPharm on March 19, 2024. FDA Approved: Yes (First approved March 14, 2024) Brand name: Rezdiffra Generic name: resmetirom Dosage form: Tablets Company: Madrigal Pharmaceuticals, Inc. Treatment for: Nonalcoholic Steatohepatitis
Resmetirom: First Approval - PubMed
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.
FDA Approves Resmetirom, First Treatment for NASH With Liver …
Mar 14, 2024 · The FDA has granted accelerated approval to resmetirom (Rezdiffra; Madrigal Pharmaceuticals), the first medication to treat nonalcoholic steatohepatitis (NASH) and liver fibrosis, in...
Rezdiffra: First FDA-Approved Drug for Treating Fatty Liver Disease
On March 14, 2024, the U.S. Food and Drug Administration (FDA) approved resmetirom under the brand name Rezdiffra for adult patients with moderate to advanced scarring of the liver due to fatty liver disease.
Madrigal Pharmaceuticals Announces FDA Approval of Rezdiffra ...
Mar 14, 2024 · Rezdiffra becomes the first and only medication approved by the FDA for the treatment of NASH (also known as “MASH”) Accelerated approval was based on Phase 3 data demonstrating that Rezdiffra improved liver fibrosis and resolved NASH in patients with noncirrhotic NASH with moderate to advanced liver fibrosis
Rezdiffra™ (resmetirom) – New drug approval • On March 14, 2024, Madrigal Pharmaceuticals announced the FDA approval of Rezdiffra (resmetirom), in conjunction with diet and exercise for the treatment of adults with noncirrhotic nonalcoholic steatohepati tis (NASH) with moderate to advanced liver fibrosis (consistent with stages
Resmetirom, the First Drug Approved by the U.S. FDA for …
On March 14, 2024, resmetirom (Rezdiffra) became the first drug approved by the U.S. FDA for treating patients with noncirrhotic nonalcoholic steatohepatitis (NASH; recently renamed metabolic dysfunction–associated steatohepatitis, or MASH) and moderate-to-advanced hepatic fibrosis. 1 This drug is an agonist of thyroid hormone receptor-β ...
Resmetirom (Rezdiffra) Receives Historic FDA Approval for
Mar 14, 2024 · In a landmark decision for the field of hepatology, the US Food and Drug Administration (FDA) has granted accelerated approval to resmetirom (Rezdiffra) for noncirrhotic nonalcoholic steatohepatitis (NASH) with moderate to advanced fibrosis, making it the first and only treatment to receive approval for the progressive liver disease. 1
The FDA approves Resmetirom for treatment of NASH
Mar 15, 2024 · This landmark approval paves the way for the first-ever medication for adults with fibrosis stage 2 or 3 due to MASH, marking a watershed moment in the pursuit of effective treatments. REZDIFFRA™ has been recognized by the FDA through breakthrough therapy and priority review designations for this crucial indication.