In March 2024, Madrigal Pharmaceuticals had a breakthrough moment when, after years of research and anticipation, the US Food and Drug Administration (FDA) granted approval for its Rezdiffra (resmetirom), a pioneering treatment for adults with F2-F3 metabolic dysfunction-associated steatohepatitis (MASH).
According to leading data and analytics company GlobalData's estimates, there are currently approximately 4.9 million diagnosed prevalent cases of MASH among individuals 18 years and older in the US.
GlobalData’s projections estimate that this number will rise to 5.2 million diagnosed prevalent cases by 2032.
This approval is the culmination of years of rigorous research and development and marks the beginning of a new era in the treatment of MASH - a liver disease that has long eluded effective therapies and seen multiple trial failures.
The significant achievement paved the way for Madrigal to release Rezdiffra’s first full quarter of net sales in the US on 7 August.
With Rezdiffra now positioned as the first-line treatment for MASH in the US, Madrigal is set to lead in a market that is projected to see significant growth in the coming years.
In Madrigal’s second-quarter (Q2) financial statement, covering the first full quarter of Rezdiffra’s availability, the therapy generated $14.6m in US net sales, with more than 2,000 patients beginning treatment.
According to GlobalData estimates, the MASH market is anticipated to reach sales of $25.7bn in 2032 across the seven major markets (the US, France, Germany, Italy, Spain, the UK, and Japan), making the stakes incredibly high for Madrigal.
Despite an initially subdued investor response, Madrigal’s CEO, Bill Sibold, remains optimistic and emphasised the importance of establishing infrastructure and expanding insurance coverage.
More than 50% of commercial patients in the US were covered by the end of Q2 2024, and the company aims to increase this to 80% by the end of the year.
Rezdiffra’s appeal lies in its noninvasive nature, as it uses noninvasive tests instead of liver biopsies, which has facilitated its adoption among hepatologists.
However, gastroenterologists have been slower to adopt Rezdiffra, given that MASH is not their primary focus.
Notably, a 2023 vote by the Institute for Clinical and Economic Review affirmed that resmetirom offers superior health benefits compared to lifestyle management alone.
Madrigal is actively working to boost awareness and adoption of Rezdiffra through industry events such as Digestive Disease Week and is expected to have a strong presence at the American College of Gastroenterology Annual Meeting 2024, held from 25-30 October in Philadelphia.
The company is also preparing for a European launch, with a regulatory decision anticipated in mid-2025 following a Q1 2024 filing.
The updated guidelines from the European Association for the Study of the Liver, European Association for the Study of Diabetes, and European Association for the Study of Obesity position Rezdiffra as a first-line treatment for MASH, contingent upon its approval.
The ongoing MAESTRO-NASH outcomes trial, which is expected to be completed in December 2026, may extend Rezdiffra’s use to patients with more advanced liver disease, potentially broadening its market.
Additionally, competition is expected to intensify with Novo Nordisk preparing to launch semaglutide, which is projected for US approval in Q1 2026.
Currently, Madrigal remains focused on solidifying Rezdiffra’s market presence in anticipation of substantial future growth.
