The FDA approval was supported by positive results from Phase 3 SONICS and LOGICS studies evaluating Recorlev in treating Cushing's syndrome
FDA Centre for Drug Evaluation and Research. (Credit: The U.S. Food and Drug Administration/Wikipedia.)
Xeris Biopharma has received the US Food and Drug Administration (FDA) approval for its Recorlev (levoketoconazole) to treat a type of Cushing’s syndrome.
Recorlev is a cortisol synthesis inhibitor, indicated for treating endogenous hypercortisolemia in adult patients with Cushing’s syndrome, who are not eligible for surgery.
It is a pure 2S,4R enantiomer of ketoconazole, that significantly reduced mean urine free cortisol, in two Phase 3 studies.
The drug received orphan drug designation from the FDA and the European Medicines Agency to treat endogenous Cushing’s syndrome.
Xeris Biopharma chairman and CEO Paul Edick said: “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 organisation can begin rapidly working to help address the needs of Cushing’s syndrome patients in the US who are treated with prescription therapy.
“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.”
The FDA approval was based on positive safety and efficacy data from two Phase 3 studies that jointly evaluated 166 patients with endogenous Cushing’s syndrome.
The SONICS study met its primary and key secondary endpoints, significantly reducing and normalising mean urinary free cortisol concentrations without a dose increase.
The LOGICS study has also met its primary and key secondary endpoints, confirmed the efficacy and safety of Recorlev and maintained the therapeutic response than placebo.
Endogenous Cushing’s syndrome is a rare but serious and potentially mortal endocrine disease caused by a chronic increase in cortisol exposure, due to a tumour of the pituitary gland.
The benign tumour triggers an overproduction of cortisol for a sustained period of time, resulting in characteristic physical signs and symptoms.
Xeris is a biopharmaceutical company focused on developing and commercialising unique therapies in endocrinology, neurology, and gastroenterology.
The company claimed that it has created a comprehensive programme, dubbed Xeris CareConnection, to help patients and their caregivers throughout the treatment journey.