JANSSEN SUBMITS APPLICATION TO EUROPEAN MEDICINES AGENCY SEEKING APPROVAL OF STELARA® (USTEKINUMAB) FOR TREATMENT OF ADULT PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS


If approved, ustekinumab will be the first interleukin (IL)-12/23 inhibitor licensed for the
treatment of ulcerative colitis
BEERSE, BELGIUM,  – The Janssen Pharmaceutical Companies of
Johnson & Johnson announced today the submission of a Group Type II Variation Application to
the European Medicines Agency (EMA) seeking approval of STELARA® (ustekinumab) for the
treatment of adults with moderately to severely active ulcerative colitis (UC).
Ustekinumab is a human monoclonal antibody that targets the interleukin (IL)-12 and IL-23
cytokines, which are believed to play an important role in the immune and inflammatory
responses seen in immune-mediated diseases, such as UC and Crohn’s disease.1
This submission follows a supplemental Biologics License Application (sBLA) made to the United
States’ Food and Drug Administration (FDA) on December 20, 2018, which also seeks approval
of ustekinumab for the treatment of adults with moderately to severely active UC.
“Ulcerative colitis (UC) is a chronic, painful and debilitating condition that has a significant
impact on quality of life. UC affects up to one million people across Europe, and some of these
patients struggle to achieve and maintain high levels of clinical response with currently available
therapies. This submission for ustekinumab in UC brings us one step closer to providing a new
treatment option to help address this important unmet need,” said Jaime Oliver, MD, Janssen
Therapeutic Area Lead, Immunology, Europe, Middle East & Africa, Cilag GmbH International.
“We look forward to working with the European Medicines Agency (EMA) as the application
process progresses.”
This submission is based on data from the Phase 3 UNIFI global clinical development
programme, which includes two studies (one induction and one maintenance study) evaluating
the efficacy and safety of ustekinumab for the treatment of moderately to severely active UC in
adults. Data from the Phase 3 induction study were recently presented at the 2018 American
College of Gastroenterology (ACG) and United European Gastroenterology Week (UEGW) annual
meetings, indicating that treatment with a single intravenous (IV) dose of ustekinumab induces
clinical remission and response in adults with moderately to severely active UC who previously
experienced an inadequate response or intolerance to conventional or biologic therapies.2
Results from the Phase 3 maintenance study will be presented at future scientific meetings.
“We’re excited to bring this innovative therapy, with a proven track record in Crohn’s and other
immune diseases, one step closer to being available for people living with ulcerative colitis,” said
Scott E. Plevy, MD, Gastroenterology Disease Area and IL-23 Pathway Leader, Janssen Research
& Development, LLC. “This submission builds upon our 20-year legacy of research and
development to address unmet needs of people living with inflammatory bowel diseases.”
The common (in ≥1% of patients) adverse reactions reported in controlled periods of the adult
psoriasis, psoriatic arthritis and Crohn’s disease clinical studies with ustekinumab as well as in the
post-marketing experience are: arthralgia, back pain, diarrhoea, dizziness, fatigue, headache,
injection site erythema, infection site pain, myalgia, nasopharyngitis, nausea, oropharyngeal pain,
pruritus, upper respiratory tract infection and vomiting.
Information for Editors
About ulcerative colitis
Crohn’s disease and ulcerative colitis (UC), collectively known as inflammatory bowel disease
(IBD), affect approximately three million people in Europe; of these, one million are living with
UC.
4 UC is a chronic disease of the large intestine, also known as the colon, in which the lining of
the colon becomes inflamed and develops tiny open sores, or ulcers, that produce pus and
mucus. It is the result of an abnormal response by the body’s immune system. Symptoms vary,
but may include loose and more urgent bowel movements, persistent diarrhoea, abdominal
pain, bloody stools, loss of appetite, weight loss and fatigue.5
About the UNIFI trial programme
UNIFI is a Phase 3 programme, designed to evaluate the safety and efficacy of ustekinumab
induction and maintenance dosing for the treatment of moderately to severely active UC in
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adults who demonstrated an inadequate response to, or were unable to tolerate, conventional
(i.e. corticosteroids, immunomodulators) or biologic (i.e. one or more tumour necrosis factor
[TNF]-alpha antagonists and/or vedolizumab) therapies. Both the induction and maintenance
studies were randomised, double-blind, placebo-controlled, parallel group, multicentre studies.
The induction study was of at least 8 weeks duration. Participants achieving clinical response in
the induction study were eligible to enter into the maintenance study. The maintenance study
was 44 weeks in duration, representing a total treatment duration of 1 year. The primary
endpoint of the induction study was clinical remission at week 8, and the primary endpoint for
the maintenance study was clinical remission at week 44 among responders to a single
intravenous (IV) ustekinumab infusion. After completion of the maintenance study, eligible
participants are continuing in a long-term extension study for an additional three years.
About STELARA® (ustekinumab)3
In the European Union, ustekinumab is approved for the treatment of moderate to severe plaque
psoriasis in adults who failed to respond to, who have a contraindication to, or are intolerant to
other systemic therapies including ciclosporin, methotrexate (MTX) or psoralen plus ultraviolet A
(PUVA), and is also indicated for the treatment of moderate-to-severe plaque psoriasis in
adolescent patients from the age of 12 years and older who are inadequately controlled by, or are
intolerant to, other systemic therapies or phototherapies. In addition, ustekinumab is approved
alone or in combination with MTX for the treatment of active psoriatic arthritis in adult patients
when the response to previous non-biological disease-modifying antirheumatic drug (DMARD)
therapy has been inadequate. In November 2016, the European Commission approved
ustekinumab for the treatment of adult patients with moderately to severely active Crohn’s
disease who have had an inadequate response with, lost response to, or were intolerant to either
conventional therapy or a TNF-alpha antagonist or have medical contraindications to such
therapies.
The Janssen Pharmaceutical Companies of Johnson & Johnson maintain exclusive worldwide
marketing rights to ustekinumab, which is currently approved for the treatment of moderate to
severe plaque psoriasis in 90 countries, paediatric psoriasis in 43 countries, psoriatic arthritis in
83 countries and Crohn’s disease in 62 countries.
About the Janssen Pharmaceutical Companies of Johnson & Johnson
At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a
world without disease. Transforming lives by finding new and better ways to prevent, intercept,
treat and cure disease inspires us. We bring together the best minds and pursue the most
promising science.
We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at
www.janssen.com/EMEA. Follow us on Twitter: @JanssenEMEA.
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Janssen-Cilag International NV; Janssen Research & Development, LLC and Cilag GmbH
International are part of the Janssen Pharmaceutical Companies of Johnson & Johnson.
Cautions Concerning Forward-Looking Statements
This press release contains “forward-looking statements” as defined in the Private Securities
Litigation Reform Act of 1995 regarding the submission of a Group Type II Variation Application
to the European Medicines Agency (EMA) seeking approval of STELARA® (ustekinumab) for the
treatment of adults with moderately to severely active ulcerative colitis. The reader is cautioned
not to rely on these forward-looking statements. These statements are based on current
expectations of future events. If underlying assumptions prove inaccurate or known or unknown
risks or uncertainties materialise, actual results could vary materially from the expectations and
projections of Janssen-Cilag International NV, any of the other Janssen Pharmaceutical
Companies and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to:
challenges and uncertainties inherent in product research and development, including the
uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial
success; manufacturing difficulties and delays; competition, including technological advances,
new products and patents attained by competitors; challenges to patents; product efficacy or
safety concerns resulting in product recalls or regulatory action; changes in behaviour and
spending patterns of purchasers of health care products and services; changes to applicable
laws and regulations, including global health care reforms; and trends toward health care cost
containment. A further list and descriptions of these risks, uncertainties and other factors can be
found in Johnson & Johnson’s Annual Report on Form 10-K for the fiscal year ended December
31, 2017, including in the sections captioned “Cautionary Note Regarding Forward-Looking
Statements” and “Item 1A. Risk Factors,” and in the company’s most recently filed Quarterly
Report on Form 10-Q, and the company’s subsequent filings with the Securities and Exchange
Commission. Copies of these filings are available online at www.sec.gov, www.jnj.comor on
request from Johnson & Johnson. Neither the Janssen Pharmaceutical Companies nor Johnson &
Johnson undertakes to update any forward-looking statement as a result of new information or
future events or developments.
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References
1. Croxford A, Kulig P, et al. IL-23 and IL-23 in health and disease. Cytokine Growth Factor
Rev. 2014;25(4):415–21.
2. Sands B, Sandborn W, et al. Safety and efficacy of ustekinumab induction therapy in
patients with moderate to severe ulcerative colitis: results from the Phase 3 UNIFI study.
United Europe Gastroenterology Week (UEGW) 2018, Vienna, Austria. 20–24 Oct 2018:
LB01.
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3. European Medicines Agency. Ustekinumab Summary of Product Characteristics. Available
at: https://www.ema.europa.eu/en/medicines/human/EPAR/stelara. Last updated
December 2018; last accessed December 2018.
4. Janssen Disease Lens. Available at : http://www.diseaselens.com/disease/ulcerative_colitis/.
Accessed December 2018.
5. Crohn’s and Colitis UK. Ulcerative colitis. Available at:
https://www.crohnsandcolitis.org.uk/about-inflammatory-bowel-disease/ulcerativecolitis. Accessed December 2018.

Shiwani Sharma

Shiwani Sharma was Senior Editor at PharmaShots. She has in-depth knowledge of the life sciences industry including the Pharma and Biotech sectors. Any articles written by her can be contacted at connect@pharmashots.com.

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