“The step into the American market forms the basis for further expansion of AOP Orphan. I am convinced that with an experienced partner like Eagle we will succeed in making Landiolol available to patients in the U.S. as well,” said Georg Fischer, Chief Executive Officer of AOP Orphan.
Landiolol, an ultra-short-acting, β1-selective intravenous adrenergic receptor antagonist, has been on the market in Japan for nearly 20 years, developed and brought to Europe by AOP Orphan in 2017.
As a first step in this partnership, Eagle Pharmaceuticals will support AOP Orphan with its in-depth understanding of and experience with the U.S. regulatory landscape for the submission of a new drug application (NDA) to the United States Food and Drug Administration (FDA), which is planned for early 2022. Following regulatory clearance by the FTC (Federal Trade Commission) and with the agreements now in full force and effect, Eagle Pharmaceuticals will set out to spread information about the benefits of Landiolol in critical and intensive care settings. The drug is used in the ICU to manage critically ill patients as well as in cardiac and non-cardiac surgery for fast heart rate control with limited effect on blood pressure.
“This is an exciting near-term opportunity for Eagle, with the potential to file an NDA in the first quarter of next year. The clinical advantages of Landiolol are well recognized within the medical community, and we look forward to advancing this asset for FDA approval in the United States. There is broad potential to expand the portfolio of future indications for Landiolol’s use,” stated Scott Tarriff, Chief Executive Officer of Eagle Pharmaceuticals.
Landiolol is indicated for supraventricular tachycardia and for rapid control of ventricular rate in patients with atrial fibrillation or atrial flutter in perioperative, postoperative, or other circumstances where short-term control of the ventricular rate with a short acting agent is desirable.
AOP Orphan Pharmaceuticals GmbH is an international pharmaceutical company focused on rare and special diseases. Headquartered in Vienna, Austria with subsidiaries and representative offices across Europe, Middle East and Northern Africa, the company has become an established provider of integrated therapy solutions over the past 25 years. 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 stakeholders on the other - especially the patients and their families but also the doctors and care professionals treating them. In the third quarter of 2020, AOP Orphan took over Amomed and SciPharm, two European health care companies, continuing its consistent path of growth into a pan-European health care group specializing in rare and special diseases. Find out more at www.aoporphan.com.
Eagle Pharmaceuticals, Inc. 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 RYANODEX®, BENDEKA®, BELRAPZO®, 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.