Benzinga | Jan 31, 2022 06:51AM EST

Eagle Pharmaceuticals On Track To Support Submission Of New Drug Application In Second Quarter 2022 For Landiolol, A Beta-1 Adrenergic Blocker

Eagle Pharmaceuticals, Inc. (NASDAQ:EGRX) ("Eagle" or the "Company") today announced that AOP Orphan Pharmaceuticals GmbH, Member of the AOP Health Group, ("AOP Health"), with whom it entered into a licensing agreement in August 2021, has engaged with the U.S. Food and Drug Administration ("FDA") to obtain alignment on the content and format of the pre-clinical and clinical data required to support a new drug application ("NDA") seeking approval of Landiolol, a novel therapeutic, for the short-term reduction of ventricular rate in patients with supraventricular tachycardia, including atrial fibrillation and atrial flutter.

In August 2021, Eagle entered into a licensing agreement with AOP Health, a privately owned Austrian company devoted to the treatment of rare and special diseases, for the commercial rights to Landiolol in the United States.

"We are pleased to be advancing Landiolol along the regulatory pathway. Landiolol is an important hospital emergency use product, with the potential to become a market leader in this drug class, and would complement our critical care portfolio. Landiolol has never been marketed in the United States, has robust patent protection, and we anticipate five years of new chemical entity exclusivity upon approval. Based on the FDA's responses to AOP Health's communications, we remain on track to support the NDA next quarter," stated Scott Tarriff, President and Chief Executive Officer of Eagle.

Landiolol is a short-acting, ultra-high selective beta-1 adrenoceptor blocker developed by AOP Health that has a selective effect on heart rate over cardiac contractility. Landiolol is available in two forms (20 mg/2ml concentrate, 300 mg powder) and is designed for use in emergency, cardiac critical care, operating room, and intensive care settings. It is registered in several European countries for the treatment of non-compensatory sinus tachycardia and tachycardic supraventricular arrhythmias. The drug uses a proprietary dosing algorithm to facilitate the administration.

Landiolol is already commercially available in Japan (Onoact(r)) and several European markets as RAPIBLOC(r).