CONSHOHOCKEN, PA — Madrigal Pharmaceuticals, Inc. (NASDAQ: MDGL) announced this week that the United States Patent and Trademark Office (USPTO) has issued a Notice of Allowance for a new patent covering its groundbreaking drug Rezdiffra™ (resmetirom). The patent, which protects the FDA-approved use of Rezdiffra’s weight-threshold dosing regimen, is set to extend exclusivity for the therapy through September 30, 2044.
Rezdiffra is the first and only FDA-approved treatment for adults with noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH), previously known as NASH, with moderate to advanced liver fibrosis. The condition, a progressive liver disease driven by metabolic dysfunction, has long lacked effective treatment options.
The new patent will be listed in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations, widely known as the Orange Book, providing an additional layer of intellectual property protection that can help stave off generic competition and solidify Madrigal’s market position.
“This issuance marks a pivotal milestone in our long-term Rezdiffra strategy,” said Bill Sibold, Chief Executive Officer of Madrigal. “It recognizes the value of our pioneering clinical development program and will allow our team to continue driving innovation for patients with MASH for years to come.”
The FDA approval of Rezdiffra earlier this year represented a significant breakthrough in the treatment of MASH, a condition affecting millions of patients worldwide and often leading to severe liver complications. By targeting this unmet medical need, Madrigal has established itself as a leader in the metabolic liver disease space.
With the new patent in place, Madrigal strengthens its commercial foothold and signals ongoing commitment to research and development efforts aimed at improving outcomes for patients with serious liver diseases. The company’s continued focus on innovation positions it to play a central role in shaping the future of metabolic and liver disease therapies.
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