Syndax Says FDA Gives Orphan Drug Designation to Axatilimab

Dow Jones Newswires · Apr 9, 2021 04:54

DJ Syndax Says FDA Gives Orphan Drug Designation to Axatilimab

By Stephen Nakrosis

Biopharmaceutical company Syndax Pharmaceuticals Inc. on Thursday said the U.S. Food and Drug Administration granted orphan drug designation to its axatilimab for the treatment of patients with idiopathic pulmonary fibrosis.

The FDA grants orphan drug status to treatments for rare diseases and the designation qualifies the sponsor of the drug for various development incentives, including tax credits for qualified clinical testing.

"IPF is a serious, life-limiting orphan disease, and today's orphan drug designation validates axatilimab's potential to serve as an effective therapeutic option for the currently-underserved patients living with this rare disease," said CEO Briggs W. Morrison. "Building on promising data demonstrating meaningful multiorgan clinical benefit in patients with chronic graft versus host disease, we are actively evaluating options to expand the axatilimab franchise into additional areas of high unmet need where the monocyte-macrophage lineage plays a key role in the fibrotic disease process," he added.

--Write to Stephen Nakrosis at stephen.nakrosis@wsj.com

(END) Dow Jones Newswires

April 08, 2021 16:54 ET (20:54 GMT)

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Syndax Says FDA Gives Orphan Drug Designation to Axatilimab

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