FDA Approves Xeris Biopharma’s Recorlev in Cushing’s Syndrome

Xeris Biopharma Holdings, Inc. received approval from the U.S. FDA for Recorlev (levoketoconazole) for the treatment of endogenous hypercortisolemia in adults with Cushing’s syndrome for whom surgery is not an option or has not been curative.
 
Endogenous Cushing’s syndrome (CS) is a rare, serious and potentially lethal endocrine disease caused by chronic elevated cortisol exposure – often the result of a benign tumor of the pituitary gland. Nearly 40% of prescription-treated CS patients in the U.S. are not well-controlled, underscoring the need for new, safe and effective therapeutic options to help regulate cortisol levels.
 
Given the limited options, often with safety concerns or modest efficacy, Recorlev has the potential to fill key unmet needs for patients with uncontrolled CS in a market estimated to be $2 billion annually.