By Chris Wack

Xeris Biopharma Holdings Inc. said Monday that the Food and Drug Administration granted orphan-drug exclusivity for Recorlev to treat adults with Cushing's syndrome, a potentially fatal endocrine disease.

As the first approval of Recorlev for Cushing's syndrome, Xeris is entitled to seven years of exclusivity from its FDA approval date of Dec. 30, 2021.

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

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

Write to Chris Wack at chris.wack@wsj.com

(END) Dow Jones Newswires

January 30, 2023 07:43 ET (12:43 GMT)

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