Madrigal Pharmaceuticals' Rezdiffra Achieves Remarkable Market Entry as First FDA-Approved MASH Treatment

Madrigal Pharmaceuticals' Rezdiffra (resmetirom) has experienced a successful launch since its introduction in April as the first FDA-approved treatment for metabolic dysfunction-associated steatohepatitis (MASH). The company announced that its oral, once-daily THR-β agonist generated $14.6 million in net revenue for the second quarter, significantly exceeding analysts' expectations of around $4 million in sales.

During the company's earnings call, CEO Bill Sibold expressed optimism, stating, "We're still in the early stages, but we are confident that we're building the foundation needed to create a blockbuster medicine." By June 30, over 2,000 patients were receiving treatment with Rezdiffra, which has an annual wholesale acquisition cost of $47,400. Sibold credited the specialty pharmacies within their limited distribution network for driving efficient prescription processing and noted that payers were handling medical exceptions more efficiently due to the recognized unmet need for MASH treatment.

The company had previously indicated that the time-to-fill prescriptions was expected to improve from approximately 60 days at launch to around 30 days or less within six months. Sibold reported that these efforts were paying off, with the time-to-fill running faster in the second quarter than initially anticipated.

The rapid adoption of Rezdiffra is also evident in the expanding payer coverage and the support from physicians in identifying suitable patients for the drug. This was highlighted in a recent interview with a leading endocrinologist who discussed the challenges as Madrigal launched Rezdiffra in the MASH market. The company reported that more than 50% of commercial lives now have coverage for the drug, up from 30% in the previous quarter. Additionally, over 95% of covered lives accept non-invasive tests (NITs) for diagnosis, rather than requiring biopsies.

A recent poll by FirstWord of US endocrinologists, gastroenterologists, and hepatologists showed a positive reception for Rezdiffra. Nearly 40% of doctors were already using the drug, and over 90% indicated they would recommend it to a colleague.

The positive reception in the US has spurred Madrigal Pharmaceuticals to consider direct commercialisation in Europe. The company expects a decision from the European Union by mid-2025, potentially making Rezdiffra the first treatment for MASH available in the European market.

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