Mirum Pharmaceuticals, Inc. announced that it has received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for a patent application No. 16/994,368. The allowed patent application covers methods of treating Alagille syndrome using maralixibat, an investigational treatment being evaluated for patients with Alagille syndrome, a rare and life-threatening cholestatic liver disease. The patent application is expected to issue in 2021 and will provide patent protection in the United States of the claimed methods of use of maralixibat into 2040.
Mirum has submitted a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) for maralixibat for the treatment of cholestatic pruritus in patients with Alagille syndrome one year of age and older. In March 2021, the NDA was accepted for priority review by the FDA and issued a PDUFA date of September 29, 2021. Maralixibat is also being evaluated in clinical studies for the treatment of patients with progressive familial intrahepatic cholestasis (PFIC) and biliary atresia, both of which are also cholestatic liver diseases.
A notice of allowance is a written notification issued after the USPTO makes a determination that a patent can be granted from an application. The majority of patent applications that receive a notice of allowance will proceed to issue as a U.S. patent. However, a notice of allowance is not a guarantee of patent issuance.