If Approved, STELARA® Will Be The First Interleukin
(IL)-12/23 Inhibitor Licensed For Crohn's Disease
BEERSE, Belgium--(BUSINESS WIRE)--
Janssen-Cilag International NV ("Janssen") announced today that the
Committee for Medicinal Products for Human Use (CHMP) of the European
Medicines Agency (EMA) adopted a positive opinion recommending marketing
authorisation in the European Union for the use of STELARA®
(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 tumour necrosis factor alpha (TNFα) antagonist or have
medical contraindications to such therapies. If approved, ustekinumab
will offer people with Crohn's disease a new treatment option to induce
and maintain remission of their disease symptoms.1
"Crohn's disease is a debilitating chronic condition that has a huge
impact on patients' quality of life. Patients experience unpredictable
disease flares and many have lost response to currently available
treatments, so it is vital that new therapeutic options are made
available to help control their symptoms," said Frederic Lavie, EMEA
Therapeutic Area Leader Immunology, Cardiovascular and Metabolics,
Janssen. "Ustekinumab has shown clinical benefit, is generally well
tolerated, and has a convenient dosing regimen for people living with
Crohn's disease who are eligible for a biologic therapy."
The CHMP adopted the opinion based on data from three pivotal Phase 3
trials which included approximately 1,400 patients with moderately to
severely active Crohn's disease:2,3,4
-
UNITI-1 demonstrated significantly higher rates of clinical response
at Week 6 for ustekinumab treatment groups compared with the placebo
group (p=0.003) in patients who had failed on TNFα antagonist
therapies.2 The major secondary endpoints of clinical
remission at Week 8 and clinical response at Week 8 were each also
significantly higher with IV ustekinumab induction versus IV placebo
(p < 0.001 for each).2 Clinical response was defined as a
reduction from baseline in the Crohn's Disease Activity Index (CDAI)
score of ≥100 points or being in clinical remission.Clinical
remission was defined as the CDAI < 150.2 The CDAI is a
symptom-based disease assessment tool that quantifies symptoms of
Crohn's disease and measures improvement with treatment.5
-
UNITI-2 also demonstrated significantly greater clinical response at
Week 6 with IV ustekinumab induction compared to IV placebo (p < 0.001)
in a population of patients who had previously failed conventional
therapy, but who had not previously failed TNFα antagonist therapies.
The secondary endpoints of clinical remission and response at Week 8
were also each both significantly higher in the ustekinumab groups
compared to placebo (p < 0.001 in each).3
-
IM-UNITI studied maintenance in patients who achieved clinical
response 8 weeks after a single IV infusion of ustekinumab in the
UNITI-1 and UNITI-2 Phase 3 induction studies. IM-UNITI showed that a
significantly greater proportion of patients in the subcutaneous
ustekinumab maintenance groups was in clinical remission at Week 44
versus placebo (p=0.005 in every 8 week and p=0.040 in every 12 week
groups; primary endpoint). Clinical response at Week 44 was also
significantly greater with both regimens versus placebo at Week 44.
Other major secondary endpoints of clinical remission at Week 44 among
patients in remission after induction and corticosteroid-free
remission were significantly greater for every 8 week ustekinumab
maintenance versus placebo.4
Ustekinumab was generally well tolerated as an induction and maintenance
therapy in all three studies, and the safety profile of ustekinumab in
the Crohn's disease clinical development program remained consistent
with the established safety profile of ustekinumab based upon current
labelled indications. In the induction studies (UNITI-1 and UNITI-2),
through Week 8 (placebo-controlled period), adverse events (AEs),
serious AEs (SAEs) and infections were reported in similar proportions
across ustekinumab and placebo treatment groups.2,3 Through
Week 44 (placebo-controlled period) in the maintenance study (IM-UNITI),
AEs were reported in similar proportions across ustekinumab and placebo
treatment groups, the majority of which were related to gastrointestinal
disorders, such as abdominal pain and diarrhoea, and
infections/infestations, of which, nasopharyngitis and upper respiratory
infection were the most common. SAEs occurred in 10 percent, 12 percent
and 15 percent of patients receiving ustekinumab 90 mg subcutaneously
every 8 weeks, ustekinumab 90 mg subcutaneously every 12 weeks and
placebo, respectively; 2 percent, 5 percent and 2 percent of patients
reported serious infections in these respective groups. Through the
8-week induction and 44-week maintenance phases (representing 1 year
total of therapy), no deaths or major adverse cardiovascular events were
reported. Only two randomised patients reported malignancies (one case
of basal cell carcinoma in the subcutaneous placebo group and another in
the subcutaneous ustekinumab every 8 weeks group).4
Following this positive opinion, a final decision from the European
Commission is expected later this year. Janssen is also currently
seeking approval for ustekinumab for the treatment of adult patients
with moderately to severely active Crohn's disease in the U.S.
* Ends *
Information for Editors
About Crohn's Disease
More than five million people worldwide are living with Crohn's disease
and ulcerative colitis - collectively known as inflammatory bowel
disease (IBD).6 Crohn's disease is a chronic inflammatory
condition of the gastrointestinal tract that affects nearly 250,000
Europeans.7 The cause of Crohn's disease is not known, but
the disease is associated with abnormalities of the immune system that
could be triggered by a genetic predisposition or diet and other
environmental factors. Symptoms of Crohn's disease can vary but often
include abdominal pain and tenderness, frequent diarrhoea, rectal
bleeding, weight loss and fever. There is currently no cure for Crohn's
disease.8,9
About Ustekinumab10
Ustekinumab, a human IL-12 and IL-23 antagonist, is approved in the
European Union for the treatment of moderate to severe plaque psoriasis
in adults who failed to respond to, or who have a contraindication to,
or are intolerant to other systemic therapies including ciclosporin,
methotrexate (MTX) or psoralen plus ultraviolet A. Ustekinumab 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 therapy has been inadequate.
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 87
countries, psoriatic arthritis in 71 countries and paediatric psoriasis
in 34 countries.
Important Safety Information
For complete European Union (EU) prescribing information, please visit: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/000958/human_med_001065.jsp&mid=WC0b01ac058001d124
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.
Cautions Concerning Forward-Looking Statements
This press release contains "forward-looking statements" as defined in
the Private Securities Litigation Reform Act of 1995 regarding potential
regulatory approvals and benefits of a new treatment option. 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 or
Johnson & Johnson. Risks and uncertainties include, but are not limited
to: challenges inherent in product research and development, including
uncertainty of clinical success and obtaining regulatory approvals;
uncertainty of commercial success for new products; competition,
including technological advances, new products and patents attained by
competitors; challenges to patents; changes to applicable laws and
regulations, including global health care reforms; and trends toward
health care cost containment. A further list and description 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 January
3, 2016, including in Exhibit 99 thereto, 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.com
or on request from Johnson & Johnson. None of the Janssen Pharmaceutical
Companies or Johnson & Johnson undertakes to update any forward-looking
statement as a result of new information or future events or
developments.
# # #
References
1. EMA. Meeting highlights from the Committee for Medicinal Products for
Human Use (CHMP). Summary of opinion 15 September 2016. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/Summary_of_opinion/human/000958/WC500212877.pdf
(last accessed September 2016).
2. Sandborn W, et al. AIBD 2015:Abstract O-001.
3. Feagan B, et al. UEGW 2015:Abstract UEG15-LB-5668.
4. Sandborn W, et al. DDW 2016:Abstract 768.
5. Best WR, et al. Gastroenterol 1976;70(3):439-44.
6. World IBD Day. Home. Available at http://www.worldibdday.org/index.html
(last accessed September 2016).
7. European Federation of Pharmaceutical Industries and Associations.
Inflammatory Bowel Disease. Available at http://www.efpia.eu/diseases/78/59/Inflammatory-Bowel-Disease
(last accessed September 2016).
8. Crohn's and Colitis UK. Crohn's disease. Available at http://www.crohnsandcolitis.org.uk/about-inflammatory-bowel-disease/crohns-disease
(last accessed September 2016).
9. IBD Determined. IBD & Colorectal Cancer. Available at http://www.ibdetermined.org/ibd-information/ibd-complications/colorectal-cancer.aspx
(last accessed September 2016).
10. Summary of Product Characteristics Stelara 45 mg solution.
Janssen-Cilag International NV. Last updated June 2015.
September 2016
PHGB/STE/0716/0003
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