AMGEN ANNOUNCES POSITIVE TOP-LINE RESULTS FROM PHASE 3 STUDY OF ABP 959, BIOSIMILAR CANDIDATE TO SOLIRIS® (ECULIZUMAB)

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Examine Evaluated the Efficacy, Security and Immunogenicity of ABP 959 In comparison with Eculizumab in Sufferers With Paroxysmal Nocturnal Hemoglobinuria

THOUSAND OAKS, Calif., Aug. 23, 2022 /PRNewswire/ — Amgen (NASDAQ: AMGN) at present introduced constructive top-line outcomes from the DAHLIA research, a randomized, double-blind, active-controlled, two-period crossover Section 3 research evaluating the efficacy and security of ABP 959, a biosimilar candidate to SOLIRIS® (eculizumab), in contrast with SOLIRIS in grownup sufferers with paroxysmal nocturnal hemoglobinuria (PNH).

The research met its main endpoints, demonstrating no clinically significant variations between ABP 959 and SOLIRIS based mostly on the management of intravascular hemolysis as measured by lactate dehydrogenase (LDH) at week 27 for the parallel comparability, and the time-adjusted space below the impact 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 comparability. The security and immunogenicity profile of ABP 959 was akin to SOLIRIS.

“At present’s constructive outcomes with ABP 959 exhibit related efficacy, security and immunogenicity because the reference product, additional highlighting Amgen’s dedication to offering sufferers with entry to high-quality, biologic therapies,” mentioned David M. Reese, M.D., government vice chairman of Analysis and Growth at Amgen. “We sit up for working with regulators to make this potential biosimilar possibility out there to sufferers.”

Detailed outcomes of this research shall be offered at a future medical congress and submitted for publication.

ABP 959 is being developed as a biosimilar candidate to SOLIRIS, for the remedy of PNH and different indications. ABP 959 has the identical pharmaceutical type, dosage energy, route of administration and dosing routine as licensed eculizumab in the US (U.S.) and European Union (EU).

This isn’t a suggestion on the market. ABP 959 is at the moment not out there commercially.

Amgen has a complete of 11 biosimilars in its portfolio, together with 5 which have been permitted within the U.S., three which can be permitted within the EU, and three in Section 3 improvement.

In regards to the DAHLIA Examine

This Section 3 research is a randomized, double-blind, active-controlled, two-period crossover research in grownup sufferers with paroxysmal nocturnal hemoglobinuria (PNH), who’ve been beforehand handled with eculizumab for a minimum of six months. Topics have been randomized (1:1) to obtain every investigational product (IP) in 1 of two sequences, both remedy T adopted by remedy R (TR) or remedy R adopted by remedy T (RT). Therapy was administered over 2 durations: Interval 1 was 52 weeks in length; Interval 2 began at week 53 with a crossover in remedy and was 26 weeks in length.

Interval 1 (week 1 to week 53):   
Therapy T: ABP 959 at a dose of 900 mg intravenously (IV) each 14 ± 2 days for 52 weeks 
Therapy R: eculizumab at a dose of 900 mg IV each 14 ± 2 days for 52 weeks

Interval 2 (week 53 to week 79)   
Therapy T: ABP 959 at a dose of 900 mg IV each 14 ± 2 days for 26 weeks  
Therapy R: eculizumab at a dose of 900 mg IV each 14 ± 2 days for 26 weeks

About Paroxysmal Nocturnal Hemoglobinuria

Paroxysmal nocturnal hemoglobinuria (PNH) is a uncommon, life-threatening, bone marrow dysfunction characterised by intravascular hemolytic anemia, bone marrow failure, and thrombo-embolic episodes, and is related to a big enhance in mortality, improvement of arterial and venous thrombo-embolic episodes, visceral organ injury, and speedy deterioration in high quality of life.1,2,3,4 The illness is attributable to the growth of a clone of hematopoietic cells missing glycosylphosphatidylinositol-anchored membrane proteins, which ends up in power, complement-mediated intravascular hemolysis.2

About ABP 959

ABP 959 is an investigational biosimilar candidate to SOLIRIS® (eculizumab) for the remedy of paroxysmal nocturnal hemoglobinuria (PNH) and different indications. It’s a monoclonal antibody that particularly binds to the complement protein C5 and inhibits the development of each the classical and different complement cascades. ABP 959 has the identical amino acid sequence as eculizumab and equal non-clinical pharmacologic operate, based mostly on complete bioanalytical assays.

About Amgen Biosimilars

Amgen is dedicated to constructing upon Amgen’s expertise within the improvement and manufacturing of revolutionary human therapeutics to broaden Amgen’s attain to sufferers with severe sicknesses. Biosimilars assist to keep up Amgen’s dedication to attach sufferers with very important medicines, and Amgen is effectively positioned to leverage its almost 4 many years of expertise in biotechnology to create high-quality biosimilars and reliably provide them to sufferers worldwide.

For extra data, go to www.amgenbiosimilars.com.

About Amgen 

Amgen is dedicated to unlocking the potential of biology for sufferers affected by severe sicknesses by discovering, creating, manufacturing and delivering revolutionary human therapeutics. This method begins through the use of instruments like superior human genetics to unravel the complexities of illness and perceive the basics of human biology.  

Amgen focuses on areas of excessive unmet medical want and leverages its experience to attempt for options that enhance well being outcomes and dramatically enhance individuals’s lives. A biotechnology pioneer since 1980, Amgen has grown to be one in every of the world’s main impartial biotechnology firms, has reached thousands and thousands of sufferers around the globe and is creating a pipeline of medicines with breakaway potential.  

Amgen is likely one of the 30 firms that comprise the Dow Jones Industrial Common and can also be a part of the Nasdaq-100 index.  In 2021, Amgen was named one of many 25 World’s Finest Workplaces™ by Fortune and Nice Place to Work™ and one of many 100 most sustainable firms on the planet by Barron’s.

For extra data, go to www.amgen.com and comply with us on www.twitter.com/amgen.  

Amgen Ahead-Trying Statements

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CONTACT: Amgen, Thousand Oaks   
Kelley Davenport, 202-585-9637 (media)  
Megan Fox, 805-447-1423 (media)  
Arvind Sood, 805-447-1060 (traders) 

1 Kelly R, Richards S, Hillmen P, Hill A. The pathophysiology of paroxysmal nocturnal hemoglobinuria and remedy with eculizumab. Ther Clin Threat Manag. 2009;5:911-921.  
2 Hill A, Richards SJ, Hillmen P. Current developments within the understanding and administration of paroxysmal nocturnal haemoglobinuria. Br J Haematol. 2007;137:181-192.  
3 Hillmen P, Younger 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 scientific sequelae of intravascular hemolysis and extracellular plasma hemoglobin: a novel mechanism of human illness. JAMA. 2005;293:1653-1662.

SOURCE Amgen



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