AOP Orphan announces European approvable opinion of its ultra-short acting beta blocker Rapibloc®

Highlights: Ultra-short acting and highly cardio-selective beta blocker Rapibloc® (Landiolol) receives regulatory approval in Europe. Rapibloc® (Landiolol) allows rapid control of heart rate with a straightforward dosing scheme in a variety of perioperative and intensive care situations. Rapibloc® (Landiolol) will be launched in Europe in the first half of 2017.

AOP Orphan Pharmaceuticals AG (AOP Orphan) today announced that it received an "approvable" opinion in the pan-European licensure process of its ultra-short acting beta blocker Rapibloc® (Landiolol). Regulatory approval was received by means of a decentralized procedure involving most European countries.

Because of its short half-life and high cardio-selectivity, Rapibloc® (Landiolol) allows rapid control of heart rate in a variety of perioperative and intensive care situations.

Rapibloc® (Landiolol) will be available as a 20 mg/2 ml concentrate solution for injection, and as powder for solution for infusion in two strengths (300 mg/600 mg).

"Rapibloc® (Landiolol) is especially suitable for rapid control of heart rate in critically ill patients, its cardio-selectivity and lack of rebound effects after therapy stop, provides physicians with a new tool for highly flexible hemodynamic management. The available formulations include a concentrate which is a unique option for emergency situations, and two dry powder formulations which allow for an easy and straightforward dosing scheme. We believe that the unique clinical, pharmaceutical and practical handling features will bring many advantages of Rapibloc® over existing products", said Dr. Rudolf Widmann, CEO of AOP Orphan.

About beta-blockers
Beta-adrenergic receptor antagonists (beta-blockers) are an established means to manage tachyarrhythmias and to protect an insufficient heart from excessive sympathetic stress. Rapibloc® is an intravenous ultrashort acting beta-blocker which due to its short half-life allows tightly controlled intervention in perioperative and emergency situations. It is indicated for treatment of supraventricular tachycardia and 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, and indicated for non-compensatory sinus tachycardia where, in the physician's judgment the rapid heart rate requires specific intervention. It is not intended for use in chronic settings.

About AOP Orphan Pharmaceuticals AG (AOP Orphan)
AOP Orphan is a multinational company with headquarters in Vienna, Austria focusing on clinical research, development and distribution of medicines for rare and complex diseases. The company also provides individualized and customized services to meet and accommodate the needs of physicians and patients across Central Europe, the Middle East & Asia. Currently AOP Orphan is concentrating on orphan and complex diseases in Hematology & Oncology, Cardiology & Pulmonology, and CNS & Gastroenterology.

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