Research & Development
Xeris Biopharma granted orphan-drug exclusivity for Recorlev
30 January 2023 -

Biopharmaceutical company Xeris Biopharma Holdings Inc (Nasdaq: XERS) announced on Monday that the US Food and Drug Administration (FDA) has granted its subsidiary Xeris Pharmaceuticals Inc orphan-drug exclusivity for Recorlev (levoketoconazole) for the treatment of adult patients with endogenous Cushing's syndrome for whom surgery is not an option or has not been curative.

As this is the first approval of levoketoconazole for Cushing's syndrome, Xeris is entitled to seven years of orphan-drug market exclusivity from its FDA approval date of 30 December 2021.

This regulatory exclusivity is in addition to the patent exclusivity under Xeris' US patents covering Recorlev and its therapeutic use, which extends to at least March 2040.

Endogenous Cushing's syndrome is a rare, serious and potentially fatal endocrine disease caused by chronic elevated cortisol exposure, which is often the result of a benign tumour of the pituitary gland.

The FDA's Orphan Drug Designation program is designed to advance the development of drugs that treat a condition affecting 200,000 or fewer US patients annually.