Primary Efficacy Analysis Demonstrates no
Clinically Meaningful Differences Compared to STELARA
THOUSAND
OAKS, Calif., April 18,
2022 /PRNewswire/ -- 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 Development at 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 Psoriasis
Psoriasis 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 654
ABP 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.
About Amgen Biosimilars
Amgen is committed to building upon Amgen's experience in
the development and manufacturing of innovative human therapeutics
to expand Amgen's reach to patients with serious illnesses.
Biosimilars help to maintain Amgen's commitment to connect
patients with vital medicines, and Amgen is 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, visit www.amgenbiosimilars.com.
About Amgen
Amgen 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 be one of the
world's leading independent 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, visit www.amgen.com and follow
us on www.twitter.com/amgen.
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CONTACT: Amgen, Thousand Oaks
Kelley Davenport, 202-585-9637
(media)
Michael Strapazon, 805-313-5553
(media)
Jessica Akopyan, 805-447-0974
(media)
Arvind Sood, 805-447-1060
(investors)
- National Psoriasis Foundation. About Psoriasis. Available at:
https://www.psoriasis.org/about-psoriasis. Accessed September 22, 2020.
- National Psoriasis Foundation. Statistics. Available at:
https://www.psoriasis.org/content/statistics. Accessed September 22, 2020.
- Ortonne JP, Prinz JC. Alefacept: a novel and selective biologic
agent for the treatment of chronic plaque psoriasis. Eur J
Dermatol. 2004;14(1):41–45.
- National Psoriasis Foundation. Plaque Psoriasis. Available at:
https://www.psoriasis.org/about-psoriasis/types/plaque. Accessed
September 22, 2020.
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