Madrigal Pharma could be just weeks away from becoming the first drugmaker to claim EU approval for a treatment for metabolic dysfunction-associated steatohepatitis (MASH).
The EMA's human medicines committee, the CHMP, has recommended a conditional marketing authorisation for Madrigal's oral thyroid hormone receptor (THR) β-selective agonist Rezdiffra (resmetirom) for adults with MASH – also known as non-alcoholic steatohepatitis (NASH) – who have moderate to advanced liver scarring (fibrosis), but who have not developed cirrhosis.
The positive opinion covers wording that is very close to the indication approved for Rezdiffra by the US FDA in March 2024. Since then, US sales of Rezdiffra have ramped up quickly, reaching $137 million in the first three months of 2025, even though the company estimates that only around 5% of eligible MASH patients are being treated with the drug. Sales rose a third over the fourth quarter of 2024.
Madrigal has said that it thinks Europe is ahead of the US in terms of guidelines and preparation for a MASH product rollout, so is expecting the approval – expected in August – to inject additional growth momentum into the product.
MASH is a form of non-alcoholic fatty liver disease (NAFLD) that affects millions of people and which, for several years, has been billed as pharma's next big growth area, with some analysts predicting a market potentially worth tens of billions of dollars a year. The condition is largely associated with obesity and an unhealthy diet and lifestyle, and is on the rise in industrialised nations.
The EU's conditional approval, based on the MAESTRO-NASH study, means that the EMA will have to see positive results in two supportive studies in order for Rezdiffra to stay on the EU market in the long term.
"Today's positive CHMP opinion represents another historic first for the global MASH community," said Madrigal's chief executive Bill Sibold.
"MASH is the fastest-growing indication for liver transplantation in Europe, and we believe resmetirom has the potential to address the urgent unmet need for a foundational, liver-directed therapy to treat patients with this serious disease."
The current approvals for Rezdiffra are in patients with F2 and F3 (moderate to advanced) liver fibrosis due to MASH, and Madrigal is also running a trial in patients with F4 fibrosis and compensated cirrhosis (MAESTRO-NASH-OUTCOMES), which it reckons could potentially double the size of the market for the drug.
https://pharmaphorum.com/news/madrigal-closes-eu-approval-first-mash-treatment
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