EC approves Stelara for Crohn's disease
The European Commission has approved Stelara for the treatment of adults with moderate-to-severe Crohn’s disease for whom other therapies have failed, Janssen announced.
Stelara (ustekinumab, Janssen) is the first biologic for Crohn’s disease that targets interleukin (IL)-12 and IL-23 cytokines, which play an important role in inflammatory and immune responses, according to a press release. The FDA also recently approved Stelara in September.
“Today’s decision is an important step forward for people living with Crohn’s disease,” Frederic Lavie, Janssen’s EMEA Therapeutic Area Leader Immunology, Cardiovascular and Metabolics, 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 a positive opinion issued by the European Medicines Agency in September based on data from the phase 3 UNITI trials involving about 1,400 patients with Crohn’s disease, which showed significantly greater proportions of patients achieved clinical response and maintained clinical remission at 1 year vs. placebo. The drug was generally well tolerated in these studies, and the safety profile was consistent with previous studies in patients with psoriasis and psoriatic arthritis. Adverse event and serious adverse event rates were comparable between treatment and placebo groups, and the most common adverse events were GI-related, including abdominal pain and diarrhea, as well as infections/infestations, including nasopharyngitis and upper respiratory infections. No deaths or major adverse cardiovascular events were reported.
“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.”
The approval permits marketing of Stelara in all 28 member states of the European Union and in the European Economic Area nations of Norway, Iceland and Liechtenstein.
Disclosures: Lavie and Griffiths are employed by Janssen.