The European Commission (EC) has approved Stelara (ustekinumab) for the treatment of adults with moderate-to-severe Crohn’s disease who had no improvements with other therapies, the drug developer’s, Janssen, announced.
Stelara is a monoclonal antibody antagonist of human interleukin-12 and interleukin-23, molecules that are believed to play a role in the autoimmunity that leads to disorders such as Crohn’s disease. It was approved by the U.S. Food and Drug Administration (FDA) for the treatment of moderate-to-severe active Crohn’s disease in adults in September.
“Today’s decision is an important step forward for people living with Crohn’s disease,” Frederic Lavie, EMEA Therapeutic Area Leader for Immunology, Cardiovascular and Metabolics at Janssen, said in the press release. “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.”
The approval follows the positive opinion issued in September by the Committee for Medicinal Products for Human Use (CHMP), the scientific board of European Medicines Agency (EMA), and was based on results from the Phase 3 UNITI clinical program. This program included three studies: UNITI-1, UNITI-2 and IM-UNITI, involving 1,400 Crohn’s disease patients, and demonstrated the potential of Stelara to provide significant benefit for patients in need of an effective therapy.
In UNITI-1 (NCT01369329), Stelara was found to induce clinical response and remission in patients who had previously failed or were intolerant to treatment with one or more TNF blockers. Overall, 34% of patients reported relief from Crohn’s disease symptoms six weeks after receiving a one-time intravenous (IV) infusion of Stelara.
Results of UNITI-2, (NCT01369342), shoed that Stelara induced remission in patients who had previously failed or were intolerant to conventional therapy with immunomodulators or corticosteroids. Six weeks after the IV infusion, 56 percent of patients experienced relief from Crohn’s symptoms.
In IM-UNITI (NCT01369355), more than 50% of patients receiving Stelara by injection every eight weeks were in clinical remission after almost one year.
Stelara was well-tolerated in each of these studies, and showed a safety profile consistent with previous studies in patients with psoriasis and psoriatic arthritis.
The most commonly reported adverse events included abdominal pain and diarrhea, as well as infections/infestations, including nasopharyngitis and upper respiratory infections.
“We are proud to be bringing a new class of treatment for Crohn’s disease to this underserved patient population,” Jane Griffiths, company group chairman, Janssen Europe, Middle East and Africa, said in the press release. “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 can now be marketed in all 28 member states of the European Union (Britain is in the process of withdrawing), and in Norway, Iceland, and Liechtenstein.