Positive top-line results from phase III study of ABP 959 biosimilar to Soliris
Amgen announced positive top-line results from the DAHLIA study, a randomized, double-blind, active-controlled, two-period crossover Phase III 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. Detailed results of this study will be presented at a future medical congress and submitted for publication.
In August 2020 ,Alexion Pharmaceuticals reached a patent settlement with Amgen over Soliris (eculizumab), Alexion’s antibody treatment for the blood disease PNH. The agreement prevents Amgen’s biosimilar version of Soliris from entering the US market until 2025.The Soliris patents in the EU expired in 2020.
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