Madrigal Pharmaceuticals has moved one step closer to marketing the first treatment for metabolic dysfunction-associated steatohepatitis (MASH) in Europe after a European Medicines Agency (EMA) panel recommended approval of Rezdiffra (resmetirom).
Issued by the EMA’s Committee for Medicinal Products for Human Use (CHMP), the positive opinion signals a strong chance that its drug will be approved, though the European Commission (EC) is not mandated to follow the panel’s recommendation. A decision is expected in August 2025.
Go deeper with GlobalData
Shares in US-listed Madrigal opened 0.5% higher at market open on 20 June following the announcement. The Pennsylvania-headquartered company has a market cap of $6.3bn. In addition to MASH, the company’s therapy portfolio extends to cardiovascular and metabolic diseases.
Rezdiffra is already available in the US for the treatment of adults with noncirrhotic MASH with moderate to advanced liver fibrosis. If approved in Europe, Rezdiffra would have the same indication.
Madrigal accessed a large US market when it won accelerated US Food and Drug Administration (FDA) approval in March 2024 for the first MASH treatment in the region. MASH is the leading cause of liver transplantation in women and the second leading cause of all liver transplantation in the US, and the fastest-growing indication for liver transplantation in Europe.
MASH is a form of non-alcoholic fatty liver disease (NAFLD) that has been billed as one of pharma’s highest potential growth areas. Analysis by GlobalData forecasts sales of $25.7bn in 2032 across the seven major markets (the US, France, Germany, Italy, Spain, the UK, and Japan), meaning Madrigal first-to-market accomplishment should bode well for its financials going forward.
US Tariffs are shifting - will you react or anticipate?
Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis.
By GlobalDataFull year sales for Rezdiffra reached $180.1m in 2024, with $103.3m of that coming in Q4 alone. As with the US, Madrigal would be the sole occupant in the European MASH treatment market if its asset is approved.
Revenue for the Rezdiffra is expected to skyrocket over the coming decade, generating annual sales of nearly $5bn by 2031.
The CHMP based its decision on positive results from the pivotal Phase III MAESTRO-NASH trial (NCT03900429), which achieved both fibrosis reduction and MASH resolution primary endpoints.
Rezdiffra, administered as a daily pill, works by activating a thyroid hormone receptor that reduces liver fat accumulation.
Madrigal’s CEO Bill Sibold said: “Madrigal is singularly focused on leading the fight against MASH globally. Today’s positive CHMP opinion represents another historic first for the global MASH community. MASH is the fastest-growing indication for liver transplantation in Europe, and we believe Rezdiffra has the potential to address the urgent unmet need for a foundational, liver-directed therapy to treat patients with this serious disease.”
