Xeris announces FDA grants orphan-drug exclusivity for Recorlev

Xeris Biopharma announced that the Food and Drug Administration FDA granted its subsidiary Xeris Pharmaceuticals orphan-drug exclusivity, ODE, for Recorlev or levoketoconazole, for the treatment of adult patients with endogenous Cushing’s syndrome for whom surgery is not an option or has not been curative. As the first approval of levoketoconazole, Recorlev, for Cushing’s syndrome, Xeris is entitled to seven years of orphan-drug market exclusivity from its FDA approval date of December 30, 2021. The FDA’s Orphan Drug Designation program is designed to advance the development of drugs that treat a condition affecting 200,000 or fewer U.S. patients annually. This regulatory exclusivity is in addition to the patent exclusivity under Xeris’ U.S. patents covering Recorlev and its therapeutic use, which extends to at least March 2040.