Eagle/AOP Orphan seek FDA approval of heart disorder therapy landiolol

Jun. 01, 2022 7:47 AM ETEagle Pharmaceuticals, Inc. (EGRX)By: Ravikash, SA News Editor

Headquarters of US Food and Drug Administration (FDA)

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  • Eagle Pharmaceuticals' (NASDAQ:EGRX) said its licensing partner AOP Orphan Pharmaceuticals submitted a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval of landiolol for a type of heart disorder.
  • The filing seeks approval of landiolol for the short-term reduction of ventricular rate in patients with supraventricular tachycardia (SVT), including atrial fibrillation (irregular heart rhythm) and atrial flutter (a disorder in which heart's upper chambers beat too rapidly).
  • SVT is a condition in which the heart suddenly beats much faster than normal.
  • Eagle said landiolol reduces heart rate and has a minimal effect over cardiac contractility.
  • The companies added that the drug is approved in certain European countries to treat tachycardic supraventricular arrhythmias and non-compensatory sinus tachycardia.

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