Amgen announces positive top-line results from phase 3 study of ABP 654, biosimilar candidate to Stelara (ustekinumab) | Antibodies | News Channels -…

DetailsCategory: AntibodiesPublished on Tuesday, 19 April 2022 09:24Hits: 507

Primary Efficacy Analysis Demonstrates no Clinically Meaningful Differences Compared to STELARA

THOUSAND OAKS, CA, USA I April 18, 2022 I Amgen (NASDAQ:AMGN) today announced preliminary results from a Phase 3 study evaluating the efficacy and safety of ABP 654 compared to STELARA (ustekinumab) in adult patients with moderate to severe plaque psoriasis. The study met the primary efficacy endpoint, demonstrating no clinically meaningful differences between ABP 654 and STELARA.

The primary analysis evaluated the percentage improvement from baseline to week 12 of psoriasis area severity index (PASI), which showed a mean difference of percentage improvement between ABP 654 and STELARA of 0.14, which was within the prespecified margins. The safety profile of ABP 654 was comparable to STELARA.

"Amgen remains committed to providing patients who live with inflammatory diseases access to high-quality biosimilar medicines," said David M. Reese, M.D., executive vice president of Research and Developmentat Amgen. "We look forward to continuing to expand our inflammation portfolio to offer patients a variety of treatment options."

ABP 654 is being developed as a biosimilar candidate to STELARA, an approved human interleukin-12 and interleukin-23 antagonist indicated for the treatment of moderate to severe plaque psoriasis in adults and pediatric patients (6 years or older) who are candidates for phototherapy or systemic therapy, active psoriatic arthritis in adults, as well as for adult patients with moderately to severely active Crohn's disease and moderately to severely active ulcerative colitis.

Amgen has a total of 11 biosimilars in its portfolio, including five that have been approved by the U.S. Food and Drug Administration (FDA) and three that are approved in the EU.

About PsoriasisPsoriasis is a serious, chronic inflammatory disease that causes raised, red, scaly patches to appear on the skin, typically affecting the outside of the elbows, knees, or scalp, though it can appear on any location.1 Approximately 125 million people worldwide have psoriasis, including around 14 million people in Europe and more than 7.5 million people in the United States.2,3 About 80% of those patients have plaque psoriasis.4

About the ABP 654 Comparative Clinical Study (20190232)The Phase 3 study was a multicenter, randomized, double-blinded, comparative clinical study (study number 04607980) that evaluated the efficacy and safety of ABP 654 compared to STELARA (ustekinumab) in adult patients with moderate to severe plaque psoriasis. There were 563 patients randomized, with 281 patients in the ABP 654 group and 282 patients in the ustekinumab group.

About ABP 654ABP 654 is being developed as a biosimilar candidate to STELARA (ustekinumab), an approved human interleukin-12 and interleukin-23 antagonist indicated for the treatment of moderate to severe plaque psoriasis in adults and pediatric patients (6 years or older) who are candidates for phototherapy or systemic therapy, active psoriatic arthritis in adults, as well as for adult patients with moderately to severely active Crohn's disease and moderately to severely active ulcerative colitis. ABP 654 has the same pharmaceutical form, dosage strength, route of administration and dosing regimen as United States-licensed and European Union (EU)-approved ustekinumab.

AboutAmgenBiosimilarsAmgenis committed to building uponAmgen's experience in the development and manufacturing of innovative human therapeutics to expandAmgen's reach to patients with serious illnesses. Biosimilars help to maintainAmgen's commitment to connect patients with vital medicines, andAmgenis well positioned to leverage its over four decades of experience in biotechnology to create high-quality biosimilars and reliably supply them to patients worldwide.

For more information, visitwww.amgenbiosimilars.com.

About AmgenAmgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to beone ofthe world'sleadingindependent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

Amgen is one of the 30 companies that comprise the Dow Jones Industrial Average and is also part of the Nasdaq-100 index. In 2021, Amgen was named one of the 25 World's Best Workplaces by Fortune and Great Place to Work and one of the 100 most sustainable companies in the world by Barron's.

For more information, visitwww.amgen.comand follow us onwww.twitter.com/amgen.

SOURCE: Amgen

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Amgen announces positive top-line results from phase 3 study of ABP 654, biosimilar candidate to Stelara (ustekinumab) | Antibodies | News Channels -...