On January 30, 2023, Xeris Biopharma Holdings, Inc., a leading biopharmaceutical company, announced that the Food and Drug Administration (FDA) granted orphan-drug exclusivity (ODE) to its subsidiary Xeris Pharmaceuticals, Inc. for Recorlev® (levoketoconazole) a cortisol synthesis inhibitor for the treatment of endogenous Cushing's syndrome in adult patients for whom surgery is not viable or has not been effective.
levoketoconazole (Recorlev) being the first FDA-approved therapeutic for the treatment of endogenous hypercortisolemia, Xeris Pharmaceutical is permitted to have seven years of orphan-drug market exclusivity beginning from December 30, 2021. The FDA's Orphan Drug Designation program intends to accelerate the development of medications that treat a disease that affects 200,000 or fewer people in the United States each year. This regulatory exclusivity with the patent exclusivity under Xeris' U.S. patents for Recorlev is valid until at least March 2040.
To serve and assist this community, Xeris is dedicated to ensuring that everyone who needs access to their medications receives them. Xeris has developed Xeris CareConnection™ to provide patients and caregivers with a comprehensive program that includes financial support, one-on-one assistance, and educational materials throughout the treatment journey. Additionally, Xeris CareConnection assists healthcare providers and their teams with education on access and reimbursement.
About Xeris Pharmaceuticals, Inc.
Founded in 2005, Xeris is a growth-oriented biopharmaceutical firm dedicated to improving patients' lives via the development and commercialization of novel products in a range of therapies. Its unique technology makes medicines easier to use for patients & caregivers. The company has three commercially available products; Gvoke®, a ready-to-use liquid glucagon for treating severe hypoglycemia (very low blood sugar); Keveyis®, the first and only FDA-approved therapy for primary periodic paralysis; and Recorlev® for the treatment of endogenous hypercortisolemia. In addition, it has an increasingly broad pipeline of research and partnered projects utilizing its unique formulation technology platforms, XeriSol™ and XeriJect™, bringing forward innovative products for the firm and its partners.