Research & Development
Janssen Submits Application to European Medicines Agency Seeking Approval of Stelara for Treatment of Adult Patients with Moderately to Severely Active Ulcerative Colitis
8 January 2019 - - US-based healthcare company Johnson and Johnson's (NYSE: JNJ) The Janssen Pharmaceutical Companies business has submitted a Group Type II Variation Application to the European Medicines Agency seeking approval of Stelara (ustekinumab) for the treatment of adults with moderately to severely active ulcerative colitis, the company said.

Ustekinumab is a human monoclonal antibody that targets the interleukin -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.

This submission follows a supplemental Biologics License Application made to the United States' Food and Drug Administration on December 20, 2018, which also seeks approval of ustekinumab for the treatment of adults with moderately to severely active UC.

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 and United European Gastroenterology Week annual meetings, indicating that treatment with a single intravenous 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.

Results from the Phase 3 maintenance study will be presented at future scientific meetings.

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.

Crohn's disease and ulcerative colitis, collectively known as inflammatory bowel disease, affect approximately three m people in Europe; of these, one m are living with UC.

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.

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 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 eight 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.

Janssen said the primary endpoint of the induction study was clinical remission at week eight, and the primary endpoint for the maintenance study was clinical remission at week 44 among responders to a single intravenous ustekinumab infusion.

After completion of the maintenance study, eligible participants are continuing in a long-term extension study for an additional three years.

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 or psoralen plus ultraviolet A, 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 and 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.
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