Resmetirom (Rezdiffra) Now Available in US Pharmacies, Marks Turning Point in NASH Management

Madrigal Pharmaceuticals has announced the availability of resmetirom (Rezdiffra) in US pharmacies beginning on April 9, 2024.¹

“The introduction of Rezdiffra is completely changing the conversation about NASH in our practice. I can finally tell my appropriate patients with moderate to advanced fibrosis that we have an approved treatment to help improve fibrosis and resolve NASH. Our team at Arizona Liver Health has never felt more energized, and we recently celebrated when our first patient received Rezdiffra," said Naim Alkhouri, MD, chief medical officer, chief of Transplant Hepatology, and director of the Fatty Liver Program at Arizona Liver Health.

Rezdiffra became the first and only FDA-approved therapy in nonalcoholic steatohepatitis (NASH) on March 14, 2024, earning accelerated approval for noncirrhotic NASH with moderate to advanced fibrosis. Of note, the oral thyroid hormone receptor (THR)-β selective agonist is indicated as an adjunct to diet and exercise, and its continued approval may be contingent upon verification and description of clinical benefit in ongoing confirmatory trials.^1,2

The accelerated approval of resmetirom was based on results from the phase 3 MAESTRO-NASH trial, which remains ongoing as an outcomes study designed to generate confirmatory data to help verify clinical benefit and potentially support full approval. A second ongoing outcomes trial is evaluating progression to liver decompensation events in patients with well-compensated NASH cirrhosis treated with resmetirom versus placebo.^1,2

Check out our recent resmetirom coverage here

According to the release, the recommended dosage of resmetirom is based on actual body weight: 80 mg orally once daily for patients weighing <100 kg (220 lbs), and 100 mg orally once daily for patients weighing ≥100 kg (220 lbs). Of note, resmetirom's prescribing information does not include a liver biopsy requirement for diagnosis.¹

The release further detailed the distribution of resmetirom through a limited specialty pharmacy network, noting Madrigal has established programs to help appropriate patients who may benefit from resmetirom access treatment, including those with no insurance or who may be facing affordability challenges.¹

Prior to resmetirom’s approval, we spoke with Stephen Harrison, MD, founder and chairman of Pinnacle Clinical Research and Summit Clinical Research, to learn more about resmetirom’s role in NASH management and what it brings to the table for fibrosis benefit that glucagon-like peptide 1 (GLP-1) agonists are lacking.

Harrison has relevant disclosures with Madrigal Pharmaceuticals, Intercept Pharmaceuticals, Novartis, Novo Nordisk, 89bio, Pfizer, and others.

References:

1. ^{Madrigal Pharmaceuticals. Madrigal Pharmaceuticals Announces U.S. Availability of Rezdiffra™ (resmetirom) for the Treatment of Patients with Noncirrhotic NASH with Moderate to Advanced Liver Fibrosis. Press Releases. April 9, 2024. Accessed April 9, 2024. https://ir.madrigalpharma.com/news-releases/news-release-details/madrigal-pharmaceuticals-announces-us-availability-rezdiffratm}
2. ^{Brooks, A. Resmetirom (Rezdiffra) Receives Historic FDA Approval for Noncirrhotic NASH. HCPLive. March 14, 2024. Accessed April 9, 2024. https://www.hcplive.com/view/resmetirom-rezdiffra-receives-historic-fda-approval-for-noncirrhotic-nash}