Xeris Biopharma On Thursday Announced That The Fda Approved The Cortisol Synthesis Inhibitor Recorlev (Levoketoconazole) To Treat Endogenous Hypercortisolaemia In Adults With Cushing'S Syndrome For Whom Surgery Is Not An Option Or Has Not Been Curative. Ceo Paul Edick Said The Decision "Reinforces The Value That We Saw In Acquiring Strongbridge Biopharma'S Attractive Rare Disease Portfolio," A Deal Worth About $267 Million That Was Finalised In October.According To Xeris, The Filing Was Supported By Data From Two Phase Iii Trials That Evaluated A Combined Study Population Of 166 Patients That Is Representative Of The Adult Drug-Treated Us Population With Cushing'S Syndrome. Both The Sonics And Logics Trials Met Their Primary And Key Secondary Endpoints.Specifically, In The Sonics Study, Recorlev Demonstrated A Significant Normalisation Rate Of Urinary-Free Cortisol At Six Months Of Maintenance Therapy Without A Dose Increase. Meanwhile, Xeris Said Logics Confirmed The Efficacy And Safety Of Recorlev In Normalising And Maintaining Therapeutic Response Compared With Placebo."With This Approval, [Our]
