Pune, March 17, 2024 (GLOBE NEWSWIRE) — The recent FDA approval of Resmetirom, developed by Madrigal Pharmaceuticals, has sent ripples of excitement throughout the medical community, marking a significant achievement in the treatment of Nonalcoholic Steatohepatitis (NASH) and liver fibrosis. The FDA approved the tablet drug for the treatment of NASH, with moderate or severe liver scarring, or fibrosis, consistent with stage F2 and F3 disease, according to a product label (PDF) posted on the FDA’s website. It’s a major win for Madrigal, the FDA isn’t requiring a liver biopsy to determine a patient’s eligibility for Rezdiffra.
With being the first drug therapy treatment for NASH it provides hope to millions of Americans. In the United States, NAFLD affects approximately 80-100 million people, among whom nearly 25% progress to NASH. Many do not know they have the disease. According to the American Liver Foundation, around 25% of adults in the United States are affected by NAFLD, with approximately 5% of adults diagnosed with NASH. NASH is expected to become the leading cause of liver transplantation in the United States by 2025.
Madrigal is pricing Rezdiffra at the wholesale acquisition cost of $47,400. Previously, the influential cost analysts at the Institute for Clinical and Economic Review estimated that the drug would be deemed cost-effective based on standard thresholds if its net price ranged from $39,600 to $50,100 per year.
Rezdiffra achieved a remarkable milestone as the first drug to fulfill both objectives of MASH resolution and fibrosis improvement in a phase 3 trial. Before Rezdiffra’s groundbreaking achievement, Intercept’s Ocaliva seemed poised to claim this title for NASH treatment. However, the FDA’s second rejection in June 2023 dashed those hopes. Previously, NASH treatment landscape has been marked by numerous setbacks, with several companies, including AstraZeneca terminating the development of their NASH therapies.
Its approval sets the bar for many other companies that are also eying the field, particularly from the highly effective FGF21 analog drug class targeting more severe fibrotic NASH patient groups.
We commend Madrigal Pharmaceuticals for their innovative efforts in crafting the inaugural FDA-approved remedy for NASH among patients with fibrosis. Though the initial accessibility may be constrained to a specific patient group, we aspire for widespread availability and affordability for all individuals grappling with NASH.
Anervea suggests, looking out for the next-generation THR-β agonists, such as Viking’s VK2809 that aim to build on Rezdiffra’s success, as significant competitors. We also express a note of caution regarding the sustainability of Madrigal’s success beyond the initial two-year exclusivity period. Patients with less severe NASH are likely to receive treatment initially with incretin-modulating therapies, such as Novo Nordisk’s semaglutide or Lilly’s tirzepatide even before this drug class gains approval for NASH. This is due to the high prevalence of type 2 diabetes and obesity among NASH patients. For treating NASH, Novo is also exploring combination therapy wherein semaglutide is being studied in combination with Akero Therapeutics’ efruxifermin. Furthermore, in June 2023, Akero and Novo released encouraging findings from the Phase IIb study. The data revealed that participants who were administered the combination therapy of efruxifermin and Ozempic experienced a significant 65% relative decrease in liver fat among individuals with type 2 diabetes and liver fibrosis resulting from NASH. In contrast, those who received only Ozempic saw a mere 10% reduction in liver fat. During a Phase IIb trial, Altimmune’s incretin mimetic, pemvidutide, demonstrated a substantial 68.5% decrease in liver fat content after 12 weeks when tested as monotherapy.
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