FDA approves Recorlev for Cushing’s syndrome.- Xeris Biopharma
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.
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Xeris Biopharma announced that the European Journal of Endocrinology (EJE) published the extended evaluation (EE) results of the SONICS study (NCT01838551) evaluating longer-term effects of Recorlev (levoketoconazole) on cortisol levels, biomarkers of Cushing’s syndrome (CS) comorbidities, clinical signs and symptoms of CS, and quality of life. The manuscript also reports findings from pituitary adenoma imaging in the SONICS study
Recordati Rare Diseases announces that positive results from the Phase III LINC 4 study of Isturisa were presented on March 22 at the Endocrine Society’s Annual Meeting. Results from LINC 4, the first Phase III study in patients with Cushing’s disease to include an upfront, double-blind, randomised, placebo controlled period, demonstrated that Isturisa provided rapid and sustained normalisation of mean urinary free cortisol (mUFC) levels.