Madrigal poised to enter European MASH market after CHMP endorsement

The constructive opinion issued by the EMA’s Committee for Medicinal Merchandise for Human Use (CHMP) alerts a robust likelihood that its drug might be authorised. Piotr Swat through Shutterstock.

Madrigal Prescription drugs has moved one step nearer to advertising and marketing the primary remedy for metabolic dysfunction-associated steatohepatitis (MASH) in Europe after a European Medicines Company (EMA) panel beneficial approval of Rezdiffra (resmetirom).

Issued by the EMA’s Committee for Medicinal Merchandise for Human Use (CHMP), the constructive opinion alerts a robust likelihood that its drug might be authorised, although the European Fee (EC) shouldn’t be mandated to observe the panel’s advice. A call is predicted in August 2025.

Shares in US-listed Madrigal opened 0.5% greater at market open on 20 June following the announcement. The Pennsylvania-headquartered firm has a market cap of $6.3bn. Along with MASH, the corporate’s remedy portfolio extends to cardiovascular and metabolic illnesses.

Rezdiffra is already obtainable within the US for the remedy of adults with noncirrhotic MASH with average to superior liver fibrosis. If authorised in Europe, Rezdiffra would have the identical indication.

Madrigal accessed a big US market when it gained accelerated US Meals and Drug Administration (FDA) approval in March 2024 for the primary MASH remedy within the area. MASH is the main reason for liver transplantation in ladies and the second main reason for all liver transplantation within the US, and the fastest-growing indication for liver transplantation in Europe.

MASH is a type of non-alcoholic fatty liver illness (NAFLD) that has been billed as one in all pharma’s highest potential progress areas. Evaluation by GlobalData forecasts gross sales of $25.7bn in 2032 throughout the seven main markets (the US, France, Germany, Italy, Spain, the UK, and Japan), that means Madrigal first-to-market accomplishment ought to bode properly for its financials going ahead.

Full 12 months gross sales for Rezdiffra reached $180.1m in 2024, with $103.3m of that coming in This autumn alone. As with the US, Madrigal could be the only real occupant within the European MASH remedy market if its asset is authorised.

Income for the Rezdiffra is predicted to skyrocket over the approaching decade, producing annual gross sales of almost $5bn by 2031.

The CHMP primarily based its choice on constructive outcomes from the pivotal Part III MAESTRO-NASH trial (NCT03900429), which achieved each fibrosis discount and MASH decision major endpoints.

Rezdiffra, administered as a every day capsule, works by activating a thyroid hormone receptor that reduces liver fats accumulation.

Madrigal’s CEO Invoice Sibold stated: “Madrigal is singularly centered on main the combat towards MASH globally. Right now’s constructive CHMP opinion represents one other historic first for the worldwide MASH group. MASH is the fastest-growing indication for liver transplantation in Europe, and we consider Rezdiffra has the potential to handle the pressing unmet want for a foundational, liver-directed remedy to deal with sufferers with this severe illness.”

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