Following the announcement of Madrigal Pharmaceuticals’ second-quarter (Q2) 2024 financial results, Sravani Meka MPH, Senior Pharma Analyst at GlobalData, offers her view, “GlobalData estimates the diagnosed prevalent cases of NASH among individuals aged 18 and older in the US market to grow from 4.9 million in 2024 to 5.2 million in 2032. In March 2024, after years of research and anticipation, the FDA granted approval for Madrigal’s Rezdiffra (resmetirom), a pioneering treatment for adults with F2-F3 metabolic dysfunction-associated steatohepatitis (MASH). This significant achievement paved the way for Madrigal to release the second-quarter financial statement, Rezdiffra’s first full quarter of net sales in the US on 07 August 2024. With Rezdiffra now positioned as the first-line treatment for MASH in the US, Madrigal is set to lead in a market projected to see significant growth in the coming years.”
“In its first full quarter of availability, Rezdiffra generated $14.6 million in US net sales, with over 2,000 patients beginning treatment. According to GlobalData estimates, the MASH market is anticipated to reach $25.7 billion in 2032 across the seven major markets (the US, France, Germany, Italy, Spain, the UK, and Japan), making the stakes incredibly high for Madrigal,” she added.
“Despite an initially subdued investor response, Madrigal’s CEO, Bill Sibold, remains optimistic, emphasising the importance of establishing infrastructure and expanding insurance coverage. By the end of Q2 2024, over 50 per cent of commercial patients in the US were covered, with a target of 80 per cent coverage by the end of the year. Rezdiffra’s appeal lies in its non-invasive nature, using non-invasive tests (NITs) 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 through industry events like Digestive Disease Week (DDW) and is expected to have a strong presence at ACG 2024 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 EASL–EASD–EASO guidelines position Rezdiffra as a first-line treatment for MASH, contingent upon approval.”
“Looking ahead, the ongoing MAESTRO-NASH outcomes trial, expected to complete 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, projected for US approval in Q1 2026. For now, Madrigal remains focused on solidifying Rezdiffra’s market presence in anticipation of substantial future growth,” concludes Meka.