Madrigal Receives European Commission Approval for Rezdiffra鈩� (resmetirom) for the Treatment of MASH with Moderate to Advanced Liver Fibrosis
Madrigal Pharmaceuticals (NASDAQ:MDGL) has received European Commission approval for Rezdiffra (resmetirom), making it the first and only approved treatment for MASH (metabolic dysfunction-associated steatohepatitis) with moderate to advanced liver fibrosis in the European Union.
The conditional marketing authorization is based on successful Phase 3 MAESTRO-NASH trial results, where 91% of patients treated with Rezdiffra 100 mg showed improvement or stabilization of liver stiffness at one year. The once-daily oral treatment targets approximately 370,000 diagnosed patients across Europe.
Madrigal plans to launch Rezdiffra in Europe starting with Germany in Q4 2025, with other EU countries, Iceland, Liechtenstein, and Norway to follow based on individual reimbursement procedures.
Madrigal Pharmaceuticals (NASDAQ:MDGL) ha ottenuto l'approvazione della Commissione Europea per Rezdiffra (resmetirom), diventando il primo e unico trattamento approvato per la MASH (steatoepatite associata a disfunzione metabolica) con fibrosi epatica da moderata a avanzata nell'Unione Europea.
L'autorizzazione condizionata all'immissione in commercio si basa sui positivi risultati del trial di Fase 3 MAESTRO-NASH, in cui il 91% dei pazienti trattati con Rezdiffra 100 mg ha mostrato miglioramento o stabilizzazione della rigidit脿 epatica dopo un anno. Il trattamento orale una volta al giorno 猫 rivolto a circa 370.000 pazienti diagnosticati in tutta Europa.
Madrigal prevede di lanciare Rezdiffra in Europa a partire dalla Germania nel quarto trimestre 2025, con gli altri Paesi UE, Islanda, Liechtenstein e Norvegia che seguiranno in base alle singole procedure di rimborso.
Madrigal Pharmaceuticals (NASDAQ:MDGL) ha obtenido la aprobaci贸n de la Comisi贸n Europea para Rezdiffra (resmetirom), convirti茅ndolo en el primer y 煤nico tratamiento aprobado para MASH (esteatohepatitis asociada a disfunci贸n metab贸lica) con fibrosis hep谩tica de moderada a avanzada en la Uni贸n Europea.
La autorizaci贸n condicional de comercializaci贸n se basa en los exitosos resultados del ensayo de Fase 3 MAESTRO-NASH, donde el 91% de los pacientes tratados con Rezdiffra 100 mg mostr贸 mejor铆a o estabilizaci贸n de la rigidez hep谩tica a un a帽o. El tratamiento oral de una vez al d铆a est谩 dirigido a aproximadamente 370.000 pacientes diagnosticados en toda Europa.
Madrigal planea lanzar Rezdiffra en Europa comenzando por Alemania en el cuarto trimestre de 2025, y los dem谩s pa铆ses de la UE, Islandia, Liechtenstein y Noruega seguir谩n seg煤n sus respectivos procesos de reembolso.
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Madrigal Pharmaceuticals (NASDAQ:MDGL) a obtenu l'approbation de la Commission europ茅enne pour Rezdiffra (resmetirom), devenant ainsi le premier et unique traitement approuv茅 pour la MASH (st茅ato-h茅patite associ茅e 脿 un dysfonctionnement m茅tabolique) avec fibrose h茅patique mod茅r茅e 脿 avanc茅e dans l'Union europ茅enne.
L'autorisation de mise sur le march茅 conditionnelle repose sur les r茅sultats positifs de l'essai de phase 3 MAESTRO-NASH, o霉 91 % des patients trait茅s par Rezdiffra 100 mg ont montr茅 une am茅lioration ou une stabilisation de la rigidit茅 h茅patique apr猫s un an. Le traitement oral pris une fois par jour cible environ 370 000 patients diagnostiqu茅s 脿 travers l'Europe.
Madrigal pr茅voit de lancer Rezdiffra en Europe 脿 partir de l'Allemagne au T4 2025, les autres pays de l'UE ainsi que l'Islande, le Liechtenstein et la Norv猫ge devant suivre en fonction de leurs proc茅dures nationales de remboursement.
Madrigal Pharmaceuticals (NASDAQ:MDGL) hat die Zulassung der Europ盲ischen Kommission f眉r Rezdiffra (Resmetirom) erhalten und ist damit das erste und einzige zugelassene Mittel gegen MASH (metabolisch bedingte Steatohepatitis) mit mittelschwerer bis fortgeschrittener Leberfibrose in der Europ盲ischen Union.
Die bedingte Marktzulassung beruht auf den erfolgreichen Ergebnissen der Phase-3-Studie MAESTRO-NASH, in der 91 % der Patienten, die Rezdiffra 100 mg erhielten, nach einem Jahr eine Verbesserung oder Stabilisierung der Lebersteifigkeit zeigten. Die einmal t盲glich oral einzunehmende Therapie richtet sich an sch盲tzungsweise 370.000 diagnostizierte Patienten in Europa.
Madrigal plant, Rezdiffra in Europa mit Deutschland im 4. Quartal 2025 einzuf眉hren; andere EU-L盲nder sowie Island, Liechtenstein und Norwegen sollen je nach den nationalen Erstattungsverfahren folgen.
- First and only approved treatment for MASH in the European Union
- 91% of patients showed improvement or stabilization in liver stiffness at one year
- No biopsy requirement for treatment qualification
- Already included in European MASH treatment guidelines as first-line treatment
- Addresses large market with 370,000 diagnosed patients across Europe
- Country-by-country launch dependent on reimbursement procedures may delay widespread availability
- Conditional marketing authorization requires additional confirmatory data
- Limited to noncirrhotic MASH patients only
Insights
EU approval of Rezdiffra as first MASH treatment creates major revenue opportunity for Madrigal with 370,000 potential European patients.
The European Commission's conditional marketing authorization for Rezdiffra represents a landmark achievement for Madrigal Pharmaceuticals in the MASH treatment landscape. As the first and only approved therapy for MASH in the European Union, Rezdiffra gains first-mover advantage in an untapped market with approximately
The approval's commercial significance is amplified by the label's broad applicability - notably, no liver biopsy requirement for treatment qualification, which substantially reduces barriers to prescription. The targeted population of moderate to advanced fibrosis (F2-F3) patients represents those with the highest unmet medical need and greatest likelihood of disease progression.
Madrigal's strategic rollout plan, beginning with Germany in Q4 2025, indicates a methodical approach to navigating Europe's complex reimbursement landscape. Germany, with its favorable early access provisions, offers the fastest path to commercialization. Subsequent country launches will likely follow reimbursement approvals, creating a staged revenue ramp.
The conditional approval based on the MAESTRO-NASH trial data is particularly meaningful as it validates both primary endpoints: fibrosis reduction and MASH resolution. The documented
Rezdiffra's inclusion in European MASH treatment guidelines as a first-line therapy further cements its position as the standard of care, potentially accelerating adoption among specialists already familiar with the drug through clinical trials. This approval transforms Madrigal from a clinical-stage to commercial-stage company with substantial European revenue potential in the near term.
This approval represents a paradigm shift in MASH management across Europe. The absence of biopsy requirements in the approved label removes a significant diagnostic barrier that has historically limited treatment access. MASH diagnosis traditionally requires invasive liver biopsy, which many patients resist and many centers have limited capacity to perform.
The clinical efficacy demonstrated in the MAESTRO-NASH trial is compelling from a hepatology perspective. Beyond the primary endpoints of fibrosis reduction and MASH resolution, the improvements in noninvasive markers are particularly valuable for clinical practice. The
The focus on patients with moderate to advanced fibrosis (F2-F3) properly targets those at highest risk of progression to cirrhosis and liver-related complications. These patients have 10-17 times higher risk of liver-related mortality compared to the general population and urgently need intervention.
As a THR-尾 agonist, Rezdiffra's mechanism addresses multiple pathophysiological components of MASH - reducing liver fat, improving insulin sensitivity, and directly modulating inflammatory and fibrotic pathways in the liver. The documented improvements in liver enzymes, lipid profiles, and quality of life metrics suggest benefits beyond the histological endpoints.
European hepatologists have been anticipating this approval since Rezdiffra was incorporated into treatment guidelines. The established clinical trial infrastructure across European academic centers means many specialists already have experience with the drug, potentially accelerating real-world adoption. This approval transforms MASH from a "diagnose and monitor" condition to a treatable disease with a specific therapeutic pathway.
- Rezdiffra is the first and only medication approved for people living with MASH in the European Union听听
- Conditional marketing authorization is based on positive results from the pivotal Phase 3 MAESTRO-NASH trial demonstrating Rezdiffra reduced fibrosis, resolved MASH and improved key noninvasive tests
- Rezdiffra is already included in European MASH treatment guidelines as a first-line treatment
- Madrigal is planning for its first European launch in Germany in the fourth quarter of 2025
CONSHOHOCKEN, Pa., Aug. 19, 2025 (GLOBE NEWSWIRE) -- Madrigal Pharmaceuticals, Inc. (NASDAQ: MDGL), a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), today announced that the European Commission (EC) has granted conditional marketing authorization for Rezdiffra (resmetirom) for the treatment of adults with noncirrhotic MASH with moderate to advanced liver fibrosis. Rezdiffra is now the first and only approved therapy in the European Union (EU) for the treatment of MASH.
Bill Sibold, Chief Executive Officer of Madrigal, stated, 鈥淭his approval of Rezdiffra marks a historic breakthrough for patients in Europe living with MASH, a serious and progressive liver disease. MASH is the fastest-growing indication for liver transplantation in Europe, but until now, had no approved treatment. The European labelling for Rezdiffra will set an important precedent for the entire field, with no biopsy required to qualify for treatment with Rezdiffra and a clear focus on a distinct MASH patient population with high unmet need: those with moderate to advanced fibrosis (F2-F3). These patients require liver-directed treatment because they have a 10 to 17 times higher risk of liver-related mortality and are just one or two steps away from progressing to cirrhosis.鈥�
MASH is a leading cause of liver-related mortality and an increasing burden on healthcare systems globally. Madrigal estimates that approximately 370,000 patients with MASH with moderate to advanced fibrosis are currently diagnosed and under the care of a liver specialist across Europe.
Rezdiffra is a once-daily, oral, liver-directed THR-尾 agonist designed to target key underlying causes of MASH. The EC Decision was based on Rezdiffra鈥檚 favorable benefit-risk profile 鈥� including the positive results from the pivotal聽Phase 3 , which achieved both fibrosis reduction and MASH resolution primary endpoints. Rezdiffra also reduced liver stiffness, liver fat, liver enzymes, and atherogenic lipids in the MAESTRO-NASH trial, and improved health-related quality of life. At one year,
Frank Tacke, MD, PhD, MBHA, Chairman of Hepatology & Gastroenterology at the Charit茅 鈥� Universit盲tsmedizin Berlin, Germany, stated, 鈥淭he approval of Rezdiffra is a transformational moment for the European MASH community and I鈥檓 looking forward to offering this important new treatment option to my patients with moderate to advanced fibrosis. Rezdiffra is included in the European and hundreds of patients participated in the Phase 3 studies, so there is already sound clinical experience with Rezdiffra in Europe.鈥�
This approval follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) in June 2025. The EC Decision is valid in all 27 Member States of the EU, as well as in Iceland, Liechtenstein and Norway. The timing for access to Rezdiffra in individual countries will depend on multiple factors, including the completion of reimbursement procedures. Madrigal expects to launch Rezdiffra in Europe on a country-by-country basis commencing with Germany in the fourth quarter of 2025.
About MASH
Metabolic dysfunction-associated steatohepatitis (MASH), formerly known as nonalcoholic steatohepatitis (NASH), is a serious liver disease that can progress to cirrhosis, liver failure, liver cancer, need for liver transplantation, and premature mortality. MASH is the leading cause of liver transplantation in women and the second leading cause of all liver transplantation in the U.S., and the fastest-growing indication for liver transplantation in Europe.
Once patients progress to MASH with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis), the risk of adverse liver outcomes increases dramatically: these patients have a 10-17 times higher risk of liver-related mortality as compared to patients without fibrosis. Those who progress to cirrhosis face a 42 times higher risk of liver-related mortality, underscoring the need to treat MASH before complications of cirrhosis develop. MASH is also an independent driver of cardiovascular disease, the leading cause of mortality for patients.
As MASH disease awareness improves and disease prevalence increases, the number of diagnosed patients with MASH with moderate to advanced fibrosis or compensated MASH cirrhosis (F2-F4c) is expected to grow.
About Rezdiffra
Rezdiffra is a once-daily, oral, liver-directed THR-尾 agonist designed to target key underlying causes of MASH. It is the first approved medication for the treatment of MASH in the US and EU.
Rezdiffra received accelerated approved from the U.S. Food and Drug Administration (FDA) in March 2024. In the U.S., it is indicated in conjunction with diet and exercise for the treatment of adults with noncirrhotic MASH with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis). This indication is approved under accelerated approval based on improvement of MASH and fibrosis. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
Rezdiffra received conditional marketing authorization from the European Commission (EC) in August 2025. A conditional marketing authorization is granted to a medicinal product that fulfils an unmet medical need when the benefit to public health of immediate availability outweighs the risk inherent in the fact that additional data are still required.
Rezdiffra is not approved in any geography for the treatment of patients with cirrhosis. The ongoing, fully enrolled MAESTRO-NASH OUTCOMES trial is evaluating progression to liver decompensation events in patients with compensated MASH cirrhosis treated with Rezdiffra versus placebo.
About Madrigal
Madrigal Pharmaceuticals, Inc. (Nasdaq: MDGL) is a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), a liver disease with high unmet medical need. Madrigal鈥檚 medication, Rezdiffra (resmetirom), is a once-daily, oral, liver-directed THR-尾 agonist designed to target key underlying causes of MASH. Rezdiffra is the first and only medication approved by both the FDA and European Commission for the treatment of MASH with moderate to advanced fibrosis (F2 to F3). An ongoing Phase 3 outcomes trial is evaluating Rezdiffra for the treatment of compensated MASH cirrhosis (F4c). For more information, visit .
Forward-Looking Statements
This press release includes 鈥渇orward-looking statements鈥� made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, as amended, including statements related to the expected timing for commercial launch in Europe on a country-by-country basis. Forward-looking statements are subject to a number of risks and uncertainties including, but not limited to: the assumptions underlying the forward-looking statements; risks of obtaining and maintaining regulatory approvals, including, but not limited to, potential regulatory delays or rejections; the challenges with the commercial launch of a new product, particularly for a company that did not have commercial experience prior to 2024; our history of operating losses and the possibility that we may never achieve or maintain profitability; risks associated with meeting the objectives of Madrigal鈥檚 clinical trials, including, but not limited to Madrigal鈥檚 ability to achieve enrollment objectives concerning patient numbers (including an adequate safety database), outcomes objectives and/or timing objectives for Madrigal鈥檚 trials; any delays or failures in enrollment, and the occurrence of adverse safety events; risks related to the effects of Rezdiffra鈥檚 (resmetirom鈥檚) mechanism of action; market demand for and acceptance of Rezdiffra; the potential inability to raise sufficient capital to fund ongoing operations as currently planned or to obtain financing on acceptable terms; our ability to service indebtedness and otherwise comply with debt covenants; outcomes or trends from competitive trials; future topline data timing or results; our ability to prevent and/or mitigate cyber-attacks; the uncertainties inherent in clinical testing; uncertainties concerning analyses or assessments outside of a controlled clinical trial; and changes in laws and regulations applicable to our business and our ability to comply with such laws and regulations. Undue reliance should not be placed on forward-looking statements, which speak only as of the date they are made. Madrigal undertakes no obligation to update any forward-looking statements to reflect new information, events, or circumstances after the date they are made, or to reflect the occurrence of unanticipated events. Please refer to Madrigal鈥檚 submissions filed with the U.S. Securities and Exchange Commission(鈥淪EC鈥�), for more detailed information regarding these risks and uncertainties and other factors that may cause actual results to differ materially from those expressed or implied. Madrigal specifically discusses these risks and uncertainties in greater detail in the sections appearing in Part I, Item 1A of its Annual Report on Form 10-K for the year ended December 31, 2024, filed with the SEC on February 26, 2025, and as updated from time to time by Madrigal鈥檚 other filings with the SEC.
Investor Contact
Tina Ventura, [email protected]
Media Contact
Christopher Frates, [email protected]
FAQ
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