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FDA approves Recorlev for Cushing’s syndrome.- Xeris Biopharma

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Published:1st Jan 2022
Xeris Biopharma announced the FDA approval of Recorlev (levoketoconazole) 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 III 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. The SONICS study met its primary and key secondary endpoints, significantly reducing and normalizing mean urinary free cortisol concentrations without a dose increase (detailed results here). LOGICS, a double-blind, placebo-controlled randomized-withdrawal study that met its primary and key secondary endpoints, confirmed the efficacy and safety of Recorlev in normalizing and maintaining therapeutic response compared with placebo.

Condition: Cushing's Syndrome
Type: drug

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