Accelerated FDA Approval of Resmetirom for the Treatment of MASH/NASH

The FDA accelerated approval of Resmetirom for treating Metabolic Dysfunction-Associated Steatohepatitis (MASH), also known as Non-alcoholic steatohepatitis (NASH).

On March 14, 2024, the FDA announced its accelerated approval of Resmetirom for the treatment of MASH (Metabolic Dysfunction-Associated Steatohepatitis (MASH) that is commonly referred as Non-alcoholic steatohepatitis (NASH). It can be prescribed for patients exhibiting moderate to advanced liver fibrosis.

The FDA approval has been given to the the brand name Rezdiffra that is marketed by Madrigal Pharmaceuticals. Rezdiffra (resmetirom) is a thyroid hormone receptor beta (THR-β) agonist.

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‘Madrigal gains a significant edge with Rezdiffra's early approval as a leading therapy for non-cirrhotic MASH patients in F2 to F3 fibrosis stages. #liverdisease’

Sravani Meka, MPH, a Senior Pharma Analyst at GlobalData, a prominent data and analytics firm, shared her insights as follows:

The endorsement of Rezdiffra marks a pivotal moment in an area previously characterized by a lack of approved treatments and numerous developmental setbacks. This approval establishes a new benchmark for subsequent therapies under development. Future treatments are now challenged to either match or surpass the efficacy and safety benchmarks set by resmetirom’s Phase III MAESTRO studies, including MAESTRO-NASH (significant fibrosis), MAESTRO-NASH Outcomes (compensated cirrhosis), and MAESTRO-NAFLD-1 (safety).

GlobalData forecasts suggest that the NASH/MASH market could grow to $25.7 billion by 2032 across the seven major markets (the US, France, Germany, Italy, Spain, the UK, and Japan).

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Within the seven major markets, 12% to 20% of diagnosed prevalent NASH cases present severe liver damage (stage 4 liver fibrosis), denoting cirrhosis.

With the anticipated market entry of competitor drugs during 2024 to 2032, such as Novo Nordisk’s semaglutide, Lilly’s tirzepatide, and Viking’s THR-β agonist VK-2809, Rezdiffra’s early approval provides Madrigal with a significant advantage as the pioneering therapy for non-cirrhotic MASH patients with F2 to F3 fibrosis stages. Nevertheless, the durability of Madrigal’s market lead remains uncertain with the expected introduction of incretin-modulating treatments for MASH.

Madrigal’s achievement of FDA approval for Rezdiffra prescribing without the necessity for a liver biopsy marks a significant advantage. The potential biopsy requirement had been a contentious issue, raising concerns about accessibility. By eliminating this requirement, Madrigal enhances the therapy’s accessibility.

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In the aftermath of securing FDA approval, Madrigal has initiated various strategic initiatives to boost Rezdiffra’s commercialization and raise awareness among patients, healthcare professionals (HCPs), and payers about its importance in treating MASH.

The company has launched educational campaigns such as “#1 Liver Fan” and “NASH Explored” to encourage proactive liver health management. Additionally, Madrigal has undertaken several leadership changes and conducted financing rounds to support resmetirom’s clinical progression and commercial strategies.

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As Madrigal advances in the commercialization of resmetirom, it may also explore potential acquisitions or partnerships within the NASH sector, further stirring excitement and anticipation for its future endeavors.

Source-Medindia