4 September 2019 - The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the European Commission has approved the expanded use of ustekinumab for the treatment of adults with moderately to severely active ulcerative colitis, who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic or have medical contraindications to such therapies.

Ustekinumab is the first available biologic treatment to selectively target the IL-12/IL-23 pathway, an important therapeutic target in ulcerative colitis.

The EC approval is based on data from the pivotal Phase 3 UNIFI trial programme – a programme that was split into an initial Induction study (UNIFI-I) of at least eight weeks, followed by a Maintenance study (UNIFI-M) of 44 weeks – both of which demonstrated ustekinumab’s efficacy as a treatment option for patients with moderately to severely active UC who demonstrated an inadequate response to or were unable to tolerate conventional (i.e. corticosteroids or immunomodulators) or biologic (i.e. one or more tumour necrosis factor [TNF]-alpha antagonists and/or vedolizumab) therapies.

Read Janssen press release