Medical Technology

FDA approves Levoketoconazole for Cushing Syndrome

The US Food and Drug Administration has approved levoketoconazole (Recorlev, Xeris Biopharma) for the treatment of hypercortisolemia that is endogenous in adults suffering from Cushing syndrome who have surgery that is not possible or was not curative.

Endogenous Cushing Syndrome is a rare disorder that causes chronically high cortisol levels. It usually arises from an uninvolved pituitary tumor. It can result in serious complications like hypertension, diabetes tissue fragility, mood disorders as well as reproductive problems and sexual problems in women. If left untreated, half of patients will die within five years.

Levoketoconazole reduces cortisol synthesis. FDA approved the drug due to its safety and effectiveness data from two phase-3 studies that involved 166 patients with endogenous Cushing syndrome. The drug significantly decreased and normalized the mean urinary-free cortisol levels in both the single-arm, open-label SONICS trial and the randomized and placebo-controlled LOGICS trials. It also improved secondary endpoints. Long-term data will be collected through the ongoing OPTICS open-label study.

Recorlev labels include warnings about the prolongation of QT as well as life-threatening livertoxicity. Patients must undergo liver enzyme testing, ECG and correction of hypokalemia or hypomagnesemia before and during treatment.

The most common adverse reactions (occurring in > 20%) include nausea/vomiting, hypokalemia, hemorrhage/contusion, systemic hypertension, headache, hepatic injury, abnormal uterine bleeding, erythema, fatigue, abdominal pain/dyspepsia, arthritis, upper respiratory infection, myalgia, arrhythmia, back pain, insomnia/sleep disturbances, and peripheral edema.

Cushing syndrome is a rare disorder that can cause severe emotional and physical damage. Patients often suffer for years before they are diagnosed. Then, they are faced with a lack of effective treatment options. Leslie Edwin, president and CEO of the Cushing’s Support & Research Foundation, stated in a Xeris statement that FDA approval was granted for the treatment of a rare disease.

Miriam E. Tucker is a freelance journalist from the Washington, DC, area. She is a regular contributor to Medscape as well as other pieces appearing in The Washington Post, NPR’s Shots blog and Diabetes Forecast magazine. She is on Twitter at @MiriamETucker.

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