Spherix Global Insights

April 10, 2024

First ever MASH drug primed for big impact in USA

Research suggests there will likely be strong uptake for the first USA-approved therapy for metabolic dysfunction-associated steatohepatitis (MASH).

Madrigal Pharmaceuticals (Nasdaq: MDGL) recently scored a US Food and Drug Administration (FDA) nod for Rezdiffra (resmetirom) as a treatment for MASH, alongside diet and exercise.

As the first prescription medicine for a large treatment opportunity, Rezdiffra has the potential to generate revenues in excess of $3.5 billion annually before the end of the decade, according to Leerink Partners.

Madrigal can argue that the therapy will be cost-effective, despite an annual wholesale acquisition price of $47,400, due to the high healthcare costs of managing the chronic condition.

Notably, the price is well below the anticipated cost-effectiveness threshold suggested by the Institute for Clinical and Economic Review (ICER), a US pricing watchdog.

The company last month announced upsized plans for an initial public offering (IPO) in the wake of the approval, priced at a whopping $600 million.

Prescriber survey

Analysis from Spherix Global Insights, a market research firm based in Pennsylvania, USA, suggests that prescribers are poised to adopt the new medicine in large numbers.

Results from a survey reveal 82% of practitioners reported “unaided awareness” of Rezdiffra’s approval, with 70% of gastroenterologists saying they were “at least moderately familiar” with the drug.

Spherix said doctors highlighted Rezdiffra’s distinction as the first indicated product for MASH, alongside its prospective efficacy in improving fibrosis.

Rapid adoption of Rezdiffra is anticipated, Spherix said, with more than three-quarters expecting to trial the product soon after launch.

The surveyed healthcare professionals said that over one-third of MASH patients under their care would be suitable candidates for Rezdiffra.

Source: The Pharma Letter: https://www.thepharmaletter.com/article/first-ever-mash-drug-primed-for-big-impact-in-usa