Rezdiffra (resmetirom)
Manufacturer: Madrigal Pharmaceuticals
FDA Approval Date: 3/14/2024
On March 14, 2024, drug manufacturer Madrigal Pharmaceuticals announced the approval of Rezdiffra™, a new, first in class oral therapy for nonalcoholic steatohepatitis (NASH). NASH is also referred to as nonalcoholic fatty liver disease or metabolic dysfunction-associated steatohepatitis [MASH].
This disease, which impacts an estimated 6-8 million people in the U.S., is underdiagnosed and if left untreated, it can cause serious liver complications. NASH is a condition characterized by liver inflammation and fat accumulation, which can lead to liver scarring (fibrosis). It is expected to become the leading cause of liver transplantation between 2020 and 2025.
Clinical Profile
Rezdiffra™, a novel oral medication, works by activating the thyroid hormone receptor-beta (THR-beta) agonist in the liver, which reduces liver fat accumulation. It should be used in conjunction with diet and exercise to treat adults with moderate to advanced liver fibrosis.
Population:
An estimated 6-8 million people in the U.S. have NASH. The manufacturer plans to initially focus on 315,000 of these patients who are under the care of a liver specialist physician.
Pricing and Availability:
Expected U.S. launch in April 2024, at an annual wholesale acquisition cost (WAC) of $47,400.
Management Strategy:
ClearScript expects Rezdiffra™ to be classified as a specialty medication with prior authorization (PA) criteria requiring a NASH diagnosis.
References:
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