Amgen announced positive top-line results from the DAHLIA study, a randomized, double-blind, active-controlled, two-period crossover Phase 3 study evaluating the efficacy and safety of ABP 959, a biosimilar candidate to SOLIRIS® (eculizumab), compared with SOLIRIS in adult patients with paroxysmal nocturnal hemoglobinuria (PNH).
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 Amgen's commitment to providing patients with access to high-quality, biologic therapies," said David M. Reese, M.D., executive vice president of Research and Development at Amgen. "We look forward to working with regulators to make this potential biosimilar option available to patients."
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 United States (U.S.) and European Union (EU).
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