Pharma Focus Asia

Xeris Biopharma Grants FDA Orphan-drug Exclusivity for Recorlev®

Tuesday, January 31, 2023

Xeris Biopharma Holdings announced that the Food and Drug Administration (FDA) granted its subsidiary Xeris Pharmaceuticals orphan-drug exclusivity (ODE) for Recorlev® (levoketoconazole) for the treatment of adult patients with endogenous Cushing’s syndrome where surgery is not possible or resulted uncurable.

Recorlev® (levoketoconazole) is a cortisol synthesis inhibitor for the treatment of endogenous hypercortisolemia in adult patients with Cushing’s syndrome where surgery is not an option. Endogenous Cushing’s syndrome is a rare but serious and potentially fatal endocrine disease caused by chronic elevated cortisol exposure. Recorlev is the pure 2S,4R enantiomer of ketoconazole, a steroidogenesis inhibitor. Recorlev has demonstrated in two successful Phase 3 studies to significantly reduce mean urinary free cortisol.

The orphan-drug exclusivity approval for Recorlev represents a new therapeutic option addressing symptoms by treating the root cause of the disease for the underserved Cushing’s patient community.

Endogenous Cushing syndrome is a rare, serious, and potentially fatal endocrine disorder caused by chronically elevated cortisol exposure resulting of a benign  pituitary tumour. The disease is most common among adults between the ages of 30–50, and it affects women three times more often than men.

Recorlev received orphan drug designation from the FDA and the European Medicines Agency for the treatment of endogenous Cushing's syndrome.

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