Madrigal’s Rezdiffra nears historic European approval for MASH treatment

USA—Madrigal Pharmaceuticals, a US-based company, has taken a significant step toward bringing the first treatment for metabolic dysfunction-associated steatohepatitis (MASH) to Europe.

 This comes a few days after the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion recommending the conditional marketing authorization for Madrigal’s drug, Rezdiffra (resmetirom).

This medication is intended for adults with non-cirrhotic metabolic associated steatotic hepatitis (MASH) and moderate to advanced liver fibrosis, specifically stages F2 to F3.

This recommendation is a crucial milestone, as no treatment for MASH is currently approved in the European Union.

The final decision now rests with the European Commission, which is expected to announce its ruling by August 2025.

If approved, Rezdiffra would become the first licensed therapy for MASH in Europe, addressing a significant unmet medical need in a disease that is the fastest-growing cause of liver transplantation in the region.

Rezdiffra works by selectively activating thyroid hormone receptor beta (THR-β) in the liver, which helps reduce liver fat accumulation, inflammation, and fibrosis.

Its efficacy was demonstrated in the pivotal Phase III MAESTRO-NASH trial, where patients treated with resmetirom showed significant improvements in both fibrosis reduction and MASH resolution compared to placebo.

Specifically, around 29-36% of patients achieved fibrosis improvement without worsening MASH, and 23-30% experienced MASH resolution without fibrosis worsening, outperforming placebo groups substantially.

Madrigal’s CEO, Bill Sibold, highlighted the company’s commitment to leading the global fight against MASH, emphasizing that this positive CHMP opinion represents a historic breakthrough for patients suffering from this serious liver condition.

Madrigal has a market capitalization of approximately US$6.3 billion and reported full-year 2024 sales of US$180.1 million for Rezdiffra, including US$103.3 million in the last quarter alone.

Analysts forecast rapid revenue growth, with annual sales expected to reach nearly US$5 billion by 2031, reflecting the drug’s strong market potential in both the US and Europe.

Rezdiffra is already available in the US, where it received accelerated FDA approval in March 2024 for treating adults with noncirrhotic MASH with moderate to advanced liver fibrosis.

Its approval in Europe would open access to a large patient population estimated at around 47 million Europeans affected by MASH, a condition linked to metabolic dysfunction and rapidly increasing in prevalence.

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