AOP Orphan Pharmaceuticals GmbH

ICC Tribunal Rules in AOP Health's Favor Over BESREMi Licensing Dispute with PharmaEssentia

3 months ago

• The International Chamber of Commerce tribunal has ruled in favor of AOP Health in a licensing dispute over BESREMi (ropeginterferon alfa-2b), a treatment for polycythemia vera, against PharmaEssentia Corporation. • BESREMi, launched in 2019, has successfully treated approximately 9,000 patients in European, CIS, and Middle Eastern markets under AOP Health's development and commercialization rights acquired in 2009. • The ruling addresses PharmaEssentia's intentional breaches and liability claims, while the quantum of damages is yet to be determined in this latest arbitration proceeding.

FDA Approves Rapiblyk (landiolol) for Supraventricular Tachycardia

5 months ago

• The FDA has approved Rapiblyk (landiolol) for the short-term reduction of ventricular rate in adults with supraventricular tachycardia, including atrial fibrillation and atrial flutter. • Rapiblyk's approval was supported by five randomized, double-blind, placebo-controlled studies demonstrating a significant heart rate decrease in treated patients. • Landiolol is an ultra-short-acting cardioselective beta-1 adrenergic blocker that reduces heart rate with minimal impact on cardiac contractility and blood pressure. • Administered intravenously, Rapiblyk offers a new therapeutic option for rapid heart rate management in critical care settings, with hypotension being the most common adverse reaction.

FDA Approves AOP Health's Rapiblyk (Landiolol) for Supraventricular Tachycardia in Critical Care

6 months ago

• The FDA has approved Rapiblyk (landiolol) for short-term treatment of supraventricular tachycardia, including atrial fibrillation and flutter, in critical care settings. • Clinical trials demonstrated Rapiblyk's ability to rapidly reduce heart rate, with 40-90% of patients achieving target heart rate within 10 minutes. • Rapiblyk is an ultra-short-acting beta-blocker designed for intravenous use in emergency and intensive care situations, offering precise heart rate control. • This approval marks AOP Health's entry into the U.S. market, providing a new therapeutic option for rapid heart rate management in critical care patients.

FDA Approves UCB's Bimzelx (bimekizumab-bkzx) for Hidradenitis Suppurativa

6 months ago

• The FDA has approved Bimzelx (bimekizumab-bkzx) as the first IL-17A and IL-17F inhibitor for adults with moderate to severe hidradenitis suppurativa (HS). • Approval was based on Phase 3 trials (BE HEARD I and BE HEARD II) demonstrating significant improvement in HS signs and symptoms at Week 16 and sustained responses at Week 48. • Bimekizumab-bkzx showed a higher proportion of patients achieving HiSCR50 (50% improvement) compared to placebo, along with clinically meaningful improvements in HiSCR75. • This approval marks the fifth patient population in the U.S. that may benefit from Bimzelx, addressing a substantial unmet need in HS treatment.