Nonprofit’s petition aims to expedite Canadian access to Rezdiffra
Fatty Liver Alliance wants developer to apply for approval of MASH therapy
The Fatty Liver Alliance, a Canada-based advocacy group, is calling for supporters to sign a petition asking Madrigal Pharmaceuticals to apply to Canadian regulators for approval of Rezdiffra (resmetirom), the company’s oral therapy for metabolic dysfunction-associated steatohepatitis (MASH).
Rezdiffra is the first and only therapy approved anywhere for fatty liver disease, and specifically for MASH, a severe form of the condition marked by liver inflammation and scarring (fibrosis). It currently only has regulatory clearance in the U.S., but is also under review in the European Union, with a regulatory decision expected in mid-2025.
The nonprofit, created with the aim of building a supportive community for patients in Canada, works to raise awareness about fatty liver disease and advocates for better treatment and care for those diagnosed. The petition, which asks Madrigal to act urgently to work toward expanding Rezdiffra’s approval to Canada, is the Fatty Liver Alliance’s latest effort toward that goal.
It can be signed online by supporters from anywhere in the world.
“The approval of Rezdiffra in Canada would be a monumental achievement for our community, providing access to a proven treatment for those who need it most. Canadians must act now to ensure that no one is left behind,” Michael Betel, president and founder of the Fatty Liver Alliance, said in an organization press release.
The petition states: “We believe that every patient deserves the chance to receive the best possible care, and with your help, we can make this a reality for Canadians suffering from MASH.”
Rezdiffra to date is only approved in the US
Metabolic dysfunction-associated steatotic liver disease, or MASLD, previously known as nonalcoholic fatty liver disease, is a common disorder marked by the abnormal buildup of fat in the liver. It’s linked to metabolic conditions, such as obesity or type 2 diabetes.
This fat buildup in the liver usually does not cause significant problems, but for some patients, MASLD gives rise to MASH, in which fat accumulation drives inflammation and fibrosis. In the long term, MASH patients are at risk of serious liver problems, including cirrhosis — irreversible scarring and damage to the liver — liver failure, and/or liver cancer.
According to the alliance, approximately 38% of Canada’s population of 40 million may be affected by MASLD, and about 20% of those people would be expected to develop MASH.
“MASH is a significant health issue in Canada, with thousands of patients at risk of developing progressive liver disease and cirrhosis,” said Mark Swain, MD, a hepatologist at the University of Calgary in Canada, and a founding member of the Canadian NASH Network, a collaborative effort to better understand and treat MASLD/MASH.
Still, there remaims no approved therapy for MASH in Canada. That’s why the Fatty Liver Alliance sees an urgent need for Madrigal to seek regulatory approval from Health Canada for Rezdiffra in the country.
“We respectfully request that Madrigal Pharmaceuticals consider applying to Health Canada to make Rezdiffra available to Canadian patients,” the petition states. “By doing so, you will not only extend the benefits of your innovative drug to a broader population but also address a significant unmet medical need in our country.”
Rezdiffra is a once-daily oral treatment that works by activating the thyroid hormone receptor beta protein, the activity of which is impaired in the liver of MASH patients, contributing to disease progression.
We respectfully request that Madrigal Pharmaceuticals consider applying to Health Canada to make Rezdiffra available to Canadian patients. … By doing so, you will not only extend the benefits of your innovative drug to a broader population but also address a significant unmet medical need in our country.
It was approved in the U.S. earlier this year for adults with MASH and moderate to advanced liver fibrosis alongside proper diet and exercise. Clinical trial data indicate that Rezdiffra could resolve MASH, ease liver fibrosis, and improve life quality in this patient group.
The Fatty Liver Alliance believes that access to Rezdiffra in Canada could help prevent very serious health consequences, and possibly be lifesaving, for many affected Canadians.
“The availability of Rezdiffra in Canada would be a major step forward in providing these patients with the care they need,” Swain said. “I strongly support this petition and urge Canadians to add their voices.”
In the U.S., meanwhile, Madrigal has been working on its rollout of Rezdiffra. In a second-quarter 2024 financial update, the company noted that it is focusing on educating the community about the benefits of Rezdiffra, increasing the number of providers who prescribe it, and ensuring financial coverage for the medication across patient groups.
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