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Omeros Gets FDA Orphan-Drug Designation for OMS906 in PNH

By Colin Kellaher

 

Omeros Corp. on Friday said the U.S. Food and Drug Administration granted orphan-drug designation to OMS906 for the treatment of the rare blood disease paroxysmal nocturnal hemoglobinuria, or PNH.

The Seattle biopharmaceutical company said it recently completed a Phase 1 trial of OMS906 in healthy subjects and expects to begin enrollment this summer in a study assessing OMS906 in PNH patients who have had an unsatisfactory response to the C5 inhibitor ravulizumab.

The FDA's orphan-drug program gives special status to drugs and biologics for diseases and disorders that affect fewer than 200,000 people in the U.S. and provides for an extended marketing exclusivity period against competition.

 

Write to Colin Kellaher at colin.kellaher@wsj.com

 

(END) Dow Jones Newswires

July 29, 2022 09:10 ET (13:10 GMT)

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