Janssen Pharmaceutical has submitted an application to the European Medicines Agency (EMA) for the approval of its Stelara (ustekinumab) medicine to treat adults with moderately to severely active ulcerative colitis (UC).
Ustekinumab is a human monoclonal antibody designed to target the interleukin (IL)-12 and IL-23 cytokines known to be associated with the immune and inflammatory responses in immune-mediated diseases.
The drug already holds EMA approval for the treatment of moderate to severe plaque psoriasis in select adults and adolescents. It also secured the regulatory agency’s nod for treating adults suffering from moderately to severely active Crohn’s disease.
In December last year, Janssen submitted a biologics license application (sBLA) to the US Food and Drug Administration (FDA), seeking approval for Stelara to treat adults with moderately to severely active UC.
Janssen Pharmaceutical Europe, Middle East & Africa Immunology therapeutic area lead Jaime Oliver said: “UC affects up to one million people across Europe, and some of these patients struggle to achieve and maintain high levels of clinical response with currently available therapies.
“This submission for ustekinumab in UC brings us one step closer to providing a new treatment option to help address this important unmet need.”
The application submitted to EMA includes results from the Phase III Unifi global clinical development programme designed to assess the safety and efficacy of ustekinumab in patients with moderately to severely active UC.
Janssen reported data from an eight-week induction study under the UNIFI programme in October last year.
Findings revealed clinical remission and response with a single intravenous (IV) dose of the drug, compared to placebo, in patients who experienced prior inadequate response or intolerance to standard or biologic therapies.
The programme also included a maintenance study with the primary endpoint of clinical remission at week 44 among responders to a single IV infusion.