Amgen Announces Positive Top-line Results From Phase 3 DAHLIA Study Of ABP 959
(RTTNews) - Amgen, Inc. (AMGN) announced Tuesday 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.
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).
Amgen's Bkemv Approved As First Interchangeable Biosimilar To Soliris
Amgen To Open Manufacturing Site In Central Ohio; To Offer 400 Full-time Jobs
Amgen Says FDA Completes Review Of SNDA Seeking Full Approval For LUMAKRAS
Amgen, Horizon Therapeutics Reach Settlement On FTC Lawsuit; Seeks To Close Acquisition In Q4
IMF Raises Global Growth Forecast As Tariff Impact Less Severe Than Feared
TSX Rises 2% As Stocks Rally On Bargain Hunting
U.S. Small Business Confidence Weakens For First Time In 3 Months: NFIB
