Study Evaluated the Efficacy, Safety and Immunogenicity of ABP 959 Compared to Eculizumab in Patients With Paroxysmal Nocturnal Hemoglobinuria
The study met its primary endpoints, demonstrating no clinically meaningful differences between ABP 959 and SOLIRIS based on the control of intravascular hemolysis as measured by lactate dehydrogenase (LDH) at week 27 for the parallel comparison, and the time-adjusted area under the effect curve (AUEC) of LDH from week 13 to week 27, from week 39 to week 53, and from week 65 to week 79 for the crossover comparison. The safety and immunogenicity profile of ABP 959 was comparable to SOLIRIS.
"Today's positive results with ABP 959 demonstrate similar efficacy, safety and immunogenicity as the reference product, further highlighting
Detailed results of this study will be presented at a future medical congress and submitted for publication.
ABP 959 is being developed as a biosimilar candidate to SOLIRIS, for the treatment of PNH and other indications. ABP 959 has the same pharmaceutical form, dosage strength, route of administration and dosing regimen as licensed eculizumab in the
This is not an offer for sale. ABP 959 is currently not available commercially.
This Phase 3 study is a randomized, double-blind, active-controlled, two-period crossover study in adult patients with paroxysmal nocturnal hemoglobinuria (PNH), who have been previously treated with eculizumab for at least six months. Subjects were randomized (1:1) to receive each investigational product (IP) in 1 of 2 sequences, either treatment T followed by treatment R (TR) or treatment R followed by treatment T (RT). Treatment was administered over 2 periods: Period 1 was 52 weeks in duration; Period 2 started at week 53 with a crossover in treatment and was 26 weeks in duration.
Period 1 (week 1 to week 53):
Treatment T: ABP 959 at a dose of 900 mg intravenously (IV) every 14 ± 2 days for 52 weeks
Treatment R: eculizumab at a dose of 900 mg IV every 14 ± 2 days for 52 weeks
Period 2 (week 53 to week 79)
Treatment T: ABP 959 at a dose of 900 mg IV every 14 ± 2 days for 26 weeks
Treatment R: eculizumab at a dose of 900 mg IV every 14 ± 2 days for 26 weeks
Paroxysmal nocturnal hemoglobinuria (PNH) is a rare, life-threatening, bone marrow disorder characterized by intravascular hemolytic anemia, bone marrow failure, and thrombo-embolic episodes, and is associated with a significant increase in mortality, development of arterial and venous thrombo-embolic episodes, visceral organ damage, and rapid deterioration in quality of life.1,2,3,4 The disease is caused by the expansion of a clone of hematopoietic cells lacking glycosylphosphatidylinositol-anchored membrane proteins, which leads to chronic, complement-mediated intravascular hemolysis.2
ABP 959 is an investigational biosimilar candidate to SOLIRIS® (eculizumab) for the treatment of paroxysmal nocturnal hemoglobinuria (PNH) and other indications. It is a monoclonal antibody that specifically binds to the complement protein C5 and inhibits the progression of both the classical and alternative complement cascades. ABP 959 has the same amino acid sequence as eculizumab and equivalent non-clinical pharmacologic function, based on comprehensive bioanalytical assays.
Amgen is committed to building upon Amgen's experience in the development and manufacturing of innovative human therapeutics to expand Amgen's reach to patients with serious illnesses. Biosimilars help to maintain Amgen's commitment to connect patients with vital medicines, and Amgen is well positioned to leverage its nearly four decades of experience in biotechnology to create high-quality biosimilars and reliably supply them to patients worldwide.
For more information, visit www.amgenbiosimilars.com.
This news release contains forward-looking statements that are based on the current expectations and beliefs of
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1 Kelly R, Richards S, Hillmen P, Hill A. The pathophysiology of paroxysmal nocturnal hemoglobinuria and treatment with eculizumab.
2 Hill A, Richards SJ, Hillmen P. Recent developments in the understanding and management of paroxysmal nocturnal haemoglobinuria. Br
3 Hillmen P, Young NS, Schubert J, et al. The complement inhibitor eculizumab in paroxysmal nocturnal hemoglobinuria. N Engl J Med. 2006;355:1233-1243.
4 Rother RP, Bell L, Hillmen P, et al. The clinical sequelae of intravascular hemolysis and extracellular plasma hemoglobin: a novel mechanism of human disease. JAMA. 2005;293:1653-1662.
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