XERIS Biopharma Announces U.S. FDA Approval of Recorlev® (levoketoconazole)

Recorlev® (levoketoconazole) is to be used for the treatment of endogenous hypercortisolemia in adult patients with Cushing’s syndrome for whom surgery is not an option or has not been curative. The approval of Recorlev was based upon safety and efficacy data from two positive Phase 3 studies that evaluated a combined study population of 166 patients, which was representative of the adult drug-treated U.S. population with Cushing’s syndrome.