Madrigal Pharmaceuticals said the U.S. Patent and Trademark Office has issued a Notice of Allowance for a new patent covering its once-daily liver drug Rezdiffra (resmetirom), the first and only Food and Drug Administration–approved treatment for noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH) with moderate to advanced fibrosis. The patent, which focuses on the commercial weight-threshold dosing regimen specified on Rezdiffra’s FDA label, is expected to grant protection until 30 September 2044 and will be added to the FDA’s Approved Drug Products list, known as the Orange Book. Chief Executive Officer Bill Sibold called the allowance “a pivotal milestone” that reinforces the company’s long-term strategy for the therapy. Rezdiffra was cleared by the FDA earlier this year and is also being studied in an outcomes-focused Phase 3 trial in patients with compensated MASH cirrhosis. The additional intellectual-property shield is intended to help Madrigal maintain exclusivity as it scales commercial distribution and pursues broader indications.
This is a great article and if yes one would think M&A imminent. Although the next question would be how much smaller is the MASH market in a post-GLP-1 world? $MDGL On the IP topic: 🐻If generic challengers can present expert testimony that the weight-based dosing effect https://t.co/y1SsIxwi1H
Micro-dosing GLP-1 receptor agonists (drugs like semaglutide/Ozempic) could offer meaningful benefits while minimizing harmful side effects. There’s no doubt these drugs are incredibly effective for weight loss. But the high doses currently being used might be too much of a good https://t.co/JWYZ90CnYv
Το Ozempic δεν αδυνατίζει απλά, η τεράστια αλλαγή που προκαλεί αποκλειστικά και μόνο σε άντρες https://t.co/ExhAheNutV