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Xeris Biopharma Announces U.S. FDA Approval of Recorlev® (levoketoconazole) for the Treatment of Endogenous Hypercortisolemia in Adult Patients With Cushing’s Syndrome
FDA approval supported by positive results from the pivotal Phase 3 SONICS and LOGICS studies demonstrating Recorlev to be a safe and effective therapeutic
About this update from Xeris Biopharma Holdings, Inc.
[{"type":"text","content":"\nFDA approval supported by positive results from the pivotal Phase 3 SONICS and LOGICS studies demonstrating Recorlev to be a safe and effective therapeutic option in the treatment of Cushing's syndrome\n\nFDA decision follows successful completion of acquisition of Strongbridge Biopharma on October 5, 2021\n\nPost-acquisition, the Company is well-positioned to address the needs of Cushing’s syndrome patients in the U.S. who are treated with prescription therapy\n\nCommercial launch of Recorlev is planned for Q1 2022\n\n CHICAGO--(BUSINESS WIRE)--\nXeris Biopharma Holdings, Inc. (Nasdaq: XERS), a biopharmaceutical company developing and commercializing unique therapies for patient populations in endocrinology, neurology, and gastroenterology, today announced the U.S. Food and Drug Administration (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.1\n\n“We are thrilled with the FDA's approval of Recorlev as a safe and effective treatment option for patients with endogenous Cushing's syndrome. With this approval, Xeris’ experienced endocrinology-focused commercial organization can begin rapidly working to help address the needs of Cushing’s syndrome patients in the U.S. who are treated with prescription therapy,” said Paul R. Edick, Chairman and CEO of Xeris Biopharma. “Today’s announcement also reinforces the value that we saw in acquiring Strongbridge Biopharma’s attractive rare disease portfolio, which we believe will deliver compelling long-term value to our shareholders. We look forward to making Recorlev commercially available in the first quarter.”\n\nThe 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.1 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).1,2 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 maintai...