AOP Health Submits New Drug Application for Landiolol, Seeking Approval in the United States
On May 31, 2022, AOP Orphan Pharmaceuticals GmbH, Member of the AOP Health Group (“AOP Health”), applied to the U.S. Food and Drug Administration (FDA) for approval of its beta blocker landiolol – another step in the Company’s expansion in the United States.
Vienna, June 2, 2022. Headquartered in Vienna, Austria, the AOP Health Group laid the foundation for its expansion into the US market in the summer of 2021. The pharmaceutical company, which specializes in therapies for rare diseases and intensive care, signed a licensing agreement for the beta blocker Landiolol with Eagle Pharmaceuticals, a fully integrated pharmaceutical company based in New Jersey, USA, in August 2021.
Key milestone for Austrian pharmaceuticals company
Now, the AOP Health Group has taken the next step in its expansion plans by submitting the product to the U.S. Food and Drug Administration for approval. Agnes Kohl, Chief Business Officer at AOP Orphan Pharmaceuticals GmbH, Member of the AOP Health Group, commented: “Expansion into the USA is an important strategic milestone for the Group. We have found the ideal partner in Eagle Pharmaceuticals, a company with extensive experience in the field of intensive care medicine. Eagle will handle marketing and distribution in the US after the approval process has been completed.”
Scott Tarriff, President and Chief Executive Officer of Eagle Pharmaceuticals, Inc., said: “We are delighted that the new drug application was submitted to the FDA so soon after signing the licensing agreement. Landiolol is an excellent addition to our portfolio, with a great deal of potential in the USA, and we look forward to marketing this important therapeutic, if approved.”
Landiolol is an ultra short acting, cardio-selective, beta 1 blocker, which is used for the rapid heart rate control in patients with supraventricular tachycardia, including atrial fibrillation and atrial flutter with minimal effects on cardiac contractility (inotropy) and blood pressure. It was developed by the AOP Health Group and has been registered in several European countries since 2016 for the treatment of tachycardic supraventricular arrhythmias (irregular heart rates in the atrium) and non-compensatory sinus tachycardia (abnormally fast heart rates).
The AOP Health Group incorporates several companies including AOP Orphan Pharmaceuticals GmbH with its seat in Vienna, Austria (“AOP Health”). The AOP Health Group is the European pioneer for integrated therapies for rare diseases and in critical care. Over the past 25 years, the Group has become an established provider of integrated therapy solutions operating from its headquarters in Vienna, its subsidiaries and representative offices throughout Europe and the Middle East, as well as through partners worldwide. This development has been made possible by a continually high level of investment in research and development on the one hand and a highly consistent and pragmatic orientation towards the needs of all its stakeholders on the other – especially the patients and their families as well as the doctors and healthcare professionals treating them. Find out more at aop-health.com.
About Eagle Pharmaceuticals, Inc.
Eagle is a fully integrated pharmaceutical company with research and development, clinical, manufacturing and commercial expertise. Eagle is committed to developing innovative medicines that result in meaningful improvements in patients’ lives. Eagle’s commercialized products include vasopressin injection, PEMFEXY™, RYANODEX®, BENDEKA®, BELRAPZO®, TREAKISYM (Japan), and its oncology and CNS/metabolic critical care pipeline includes product candidates with the potential to address underserved therapeutic areas across multiple disease states. Additional information is available on Eagle’s website at www.eagleus.com.
Nina Roth, MAS
Head of Corporate Communications
+43 676 3131509