Xeris Biopharma has announced the availability of Recorlev® (levoketoconazole) for the treatment of endogenous hypercortisolemia in adults with Cushing syndrome for whom surgery is not an option or has not been curative.

The Company is also launching a customized support and product distribution program called Xeris CareConnection to educate and support patients receiving Recorlev treatment and help health care providers with access and reimbursement.

“Xeris is proud to introduce this meaningful new treatment option to patients in the US and is focused on meeting the needs of the rare disease community by ensuring access to treatment and providing comprehensive patient and physician support services,” said Paul R. Edick, Chairman and CEO of Xeris Biopharma.

The approval of Recorlev was based on data from the phase 3 SONICS (ClinicalTrials.gov Identifier: NCT01838551) and LOGICS (ClinicalTrials.gov Identifier: NCT03277690) studies, which evaluated the efficacy and safety of levoketoconazole, a cortisol synthesis inhibitor, in patients with endogenous Cushing syndrome. Findings from both trials showed that patients treated with Recorlev achieved a significant reduction and normalization of mean urinary free cortisol.

“Normalization of cortisol levels is the first and most important clinical objective in the treatment of Cushing syndrome and the approval of new medicines like Recorlev can aid physicians and patients to achieve this objective,” said Ken Johnson, PharmD, SVP, Global Development and Medical Affairs at Xeris.

The most common adverse reactions reported with Recorlev were 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. 

Recorlev carries a Boxed Warning regarding the risks of hepatotoxicity and dose-related QT interval prolongation. Prior to initiating treatment, baseline liver and electrocardiogram tests should be obtained and hypokalemia and hypomagnesemia should be corrected.

The product is supplied as 150mg tablets of levoketoconazole in 50-count bottles.

References

  1. Xeris Biopharma announces Recorlev® (levoketoconazole) is now commercially available for the treatment of endogenous hypercortisolemia in adult patients with Cushing’s syndrome. News release. Xeris Biopharma. Accessed January 31, 2022. https://www.businesswire.com/news/home/20220131005297/en/Xeris-Biopharma-Announces-Recorlev%C2%AE-levoketoconazole-Is-Now-Commercially-Available-for-the-Treatment-of-Endogenous-Hypercortisolemia-in-Adult-Patients-With-Cushing%E2%80%99s-Syndrome
  2. Recorlev. Package insert. Xeris Biopharma; 2021. Accessed January 3, 2022. https://www.recorlev.com/full-prescribing-information.pdf