Janssen files for US and EU approval of Stelara in Crohn’s disease

Janssen has announced that it has applied for its drug Stelara to be approved by regulators in the US and EU as a treatment for Crohn's disease.

A biologics licence application has been submitted to the US Food and Drug Administration, as well as a variation/extension application to the European Medicines Agency, seeking approval of Stelara for the treatment of adults with moderately to severely active Crohn's.

Data from the phase III UNITI clinical development programme, which includes three trials, have demonstrated the efficacy and safety of Stelara induction and maintenance treatment in this indication and served as the basis for the submissions.

Dr Newman Yeilding, head of immunology development for Janssen Research and Development, 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."

Stelara is already approved and available for the treatment of moderate to severe plaque psoriasis and active psoriatic arthritis in many countries.

It is hoped that it could be a useful new option for treating Crohn's, a chronic inflammatory condition of the gastrointestinal tract that affects approximately 250,000 Europeans.