Eagle Pharmaceuticals Gets FDA Designation for Infant Apnea Treatment

By Dean Seal

Eagle Pharmaceuticals Inc. said that regulators have granted orphan drug designation to its treatment for a breathing disorder that affects preterm infants.

The U.S. Food and Drug Administration has given the special status to ENA-001 for the treatment of apnea of prematurity, a development disorder characterized by the cessation of breathing for more than 20 seconds or the cessation of breathing for less than 20 seconds but which is accompanied by either bradycardia or hypoxemia.

The treatment is designed to work by inhibiting Big Potassium ion channels in the carotid bodies located in the neck, which stimulates breathing across multiple causes of respiratory depression.

Orphan-drug designation is a special status given to drugs that show promise for potentially treating rare, or orphan, diseases that have fewer than 200,000 cases a year in the U.S.

Write to Dean Seal at dean.seal@wsj.com

(END) Dow Jones Newswires

October 03, 2022 07:39 ET (11:39 GMT)

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