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Madrigal’s MASH drug is approved, now it’s time to build the market

ARTICLE | Regulation

FDA approves Rezdiffra as first MASH therapy

By Lauren Martz, Executive Director, Biopharma Intelligence

March 14, 2024 11:30 PM UTC

The FDA approval of Rezdiffra resmetirom from Madrigal is a landmark moment for liver disease, bringing to market a therapy that may help reverse a condition long-considered irreversible without transplant. Whether the launch lives up to high expectations will come down to patient and physician buy-in, and the extent of the barriers to reimbursement imposed by payers. 

The company is off to a good start on the reimbursement front, gaining a label for the THRβ agonist that does not require diagnostic confirmation through liver biopsy — an inclusion requirement in the company’s trials but a practice that is rarely used for diagnosis in the real world…