Janssen Biotech and Janssen-Cilag International (Janssen) have submitted two applications in the US and Europe for approval of Stelara (ustekinumab) to treat adults with moderately to severely active Crohn’s disease.
Stelara is a human monoclonal antibody that targets interleukin (IL)-12 and IL-23 cytokines, which play a major role in immune-mediated diseases including Crohn’s disease.
The disease is a chronic inflammatory condition of the gastrointestinal tract that affects around 700,000 people in the US and nearly 250,000 in Europe.
A biologics license application (BLA) was submitted to the US Food and Drug Administration (FDA) and a grouped type II variation/extension application to the European Medicines Agency (EMA).
Submissions were based on data from the Phase III UNITI clinical development programme, which includes three studies (UNITI-1, UNITI-2 and IM-UNITI) evaluating the efficacy and safety of Stelara induction and maintenance treatment in patients with moderately to severely active Crohn’s disease.
Janssen Research & Development immunology development head Newman Yeilding said: “At Janssen, we are committed to addressing the unmet medical needs of patients living with Crohn’s disease through the discovery and development of innovative therapeutics.
“We are pleased to submit applications seeking approval of Stelara for the treatment of moderately to severely active Crohn’s disease in the US and in Europe, and we look forward to collaborating with health authorities throughout the review process.”
Currently, the drug is approved to treat moderate to severe plaque psoriasis and active psoriatic arthritis in many countries.
In the US, Stelara is approved to treat adults 18 years or older with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.
The drug is also approved to treat adults with active psoriatic arthritis and can be used alone or in combination with methotrexate (MTX).
In the EU, Stelara is approved to treat moderate to severe plaque psoriasis in adults who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, MTX or psoralen plus ultraviolet A (PUVA).
It is also indicated to treat 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.
1 December 2015