European Commission approves Stelara (ustekinumab) for treatment of adults with moderately to severely active Crohn’s disease.
Janssen-Cilag International NV announced that the European Commission (EC) has approved 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 tumor necrosis factor alpha (TNFα) antagonist or have medical contraindications to such therapies.1 Stelara is the first biologic therapy for Crohn’s disease that targets interleukin (IL)-12 and IL-23 cytokines, known to play a key role in inflammatory and immune responses.
“Today’s decision is an important step forward for people living with Crohn’s disease. There is a great need for alternative effective therapeutic options to help people control their symptoms, and Stelara offers a strong clinical dataset demonstrating high rates of clinical response and remission for those whom biologic therapy is appropriate,” said Frederic Lavie, EMEA therapeutic area leader—immunology, cardiovascular and metabolics at Janssen.
The recommended dosing regimen for Stelara is an initial induction dose based on body weight (~6 mg/kg) given via a single intravenous (IV) infusion. The first subcutaneous (SC) administration of 90 mg Stelara should take place at week 8 after the intravenous dose. After this, dosing every 12 weeks is recommended. Patients who have not shown adequate response at week 8 after the first SC dose may receive a second SC dose at this time. Patients who lose response on dosing every 12 weeks may benefit from an increase in dosing frequency to every 8 weeks. Patients may subsequently be dosed every 8 weeks or every 12 weeks according to clinical judgment.1
The EC approval is based on data from three pivotal Phase 3 trials which included approximately 1,400 patients with moderately to severely active Crohn’s disease. The Phase 3 studies showed that treatment with Stelara induced clinical response and maintained clinical remission in a significantly greater proportion of adult patients with moderately to severely active Crohn’s disease after one year of therapy compared to placebo.2,3,4
“We are proud to be bringing a new class of treatment for Crohn’s disease to this underserved patient population,” said Jane Griffiths, company group chairman, Janssen Europe, Middle East and Africa. “Stelara has already helped many people living with psoriasis and psoriatic arthritis, and we are committed to working with health authorities across Europe to make it available as quickly as possible for those living with Crohn’s disease.”
Stelara was generally well tolerated as an induction and maintenance therapy in all three studies, and the safety profile of Stelara in the Crohn’s disease clinical development program remained consistent with five years of cumulative data acquired in patients with psoriasis5,6 (with Stelara subcutaneous injections up to 90 mg) and two years of safety data in patients with psoriatic arthritis who were treated with Stelara.7
In the placebo-controlled IM-UNITI maintenance study adverse events were reported in similar proportions across Stelara and placebo treatment groups, the majority of which were related to gastrointestinal disorders, such as abdominal pain and diarrhea, and infections/infestations, of which, nasopharyngitis and upper respiratory infection were the most common. Reported serious adverse events were similar in the Stelara groups compared to placebo and no deaths or major adverse cardiovascular events were reported.4
The marketing authorization approval follows a positive opinion from the European Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued on September 15, 2016.8 This approval allows for the marketing of Stelara in all 28 member states of the European Union as well as the European Economic Area countries (Norway, Iceland and Liechtenstein). Stelara also received approval by the U.S. Food and Drug Administration in September 2016 for the treatment of adult patients with moderately to severely active Crohn’s disease.9
More than five million people worldwide are living with Crohn’s disease and ulcerative colitis – collectively known as inflammatory bowel disease (IBD).10 Crohn’s disease is a chronic inflammatory condition of the gastrointestinal tract that affects nearly 250,000 Europeans, and around 18,000 new cases diagnosed each year.11 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 diarrhea, rectal bleeding, weight loss and fever. There is currently no cure for Crohn’s disease.12,13
1. EMA. Product information. http://ec.europa.eu/health/documents/community-register/html/h494.htm (last accessed November 2016)
2. Sandborn W, et al. AIBD 2015:Abstract O-001
3. Feagan B, et al. UEGW 2015:Abstract UEG15-LB-5668.
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7. Kavanaugh A, et al. Ann Rheum Dis 2016 [e-pub ahead of print]
8. 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 November 2016).
9. FDA. Biologics License Application: Approval letter. 23 September 2016. Available at: http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/761044Orig1s000ltr.pdf (last accessed November 2016).
10. World IBD Day. Home. Available at http://www.worldibdday.org/index.html (last accessed November 2016).
11. European Federation of Pharmaceutical Industries and Associations. Inflammatory Bowel Disease. Available at http://www.efpia.eu/diseases/78/59/Inflammatory-Bowel-Disease (last accessed November 2016).
12. Crohn’s and Colitis UK. Crohn’s disease. Available at http://www.crohnsandcolitis.org.uk/about-inflammatory-bowel-disease/crohns-disease (last accessed November 2016).
13. IBD Determined. IBD & Colorectal Cancer. Available at http://www.ibdetermined.org/ibd-information/ibd-complications/colorectal-cancer.aspx (last accessed November 2016).
(Source: Business Wire)