Approved Therapy Recorlev Now Wins FDA Orphan-drug Exclusivity
The U.S. Food and Drug Administration (FDA) has granted Xeris Pharmaceuticals orphan-drug exclusivity for Recorlev (levoketoconazole), its approved treatment for adults with endogenous Cushing’s syndrome. Orphan-drug exclusivity provides the company — which recently acquired the therapy’s developer, Strongbridge Biopharma — seven years of marketing exclusivity for Recorlev…