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Janssen's Crohn's treatment licensed for UK use

Published on 16/11/16 at 09:20am

Janssen, a subsidiary of Johnson & Johnson, has announced that its treatment Stelara (ustekinumab) is now licensed by the European Commission for use in the UK as an option for moderate to severely active Crohn’s disease in adult patients who do not respond adequately to conventional therapy or a TNFα antagonist or have medical contraindications to such therapies.

According to Janssen, Stelara is the first biologic therapy for the disease that targets interleukin (IL)-12 and IL-23 cytokines. The treatment’s efficacy was determined via a Phase III trial which showed “significantly greater” rates of clinical remission versus placebo in those who failed on TNFα antagonist therapies or previously failed conventional therapy over one year. Minor and serious adverse events were reported in similar capacities across both Stelara and placebo groups.

“Clinicians in the UK treating Crohn’s disease are routinely faced with the challenge of managing patients who have disease refractory to standard treatments. To have a new licensed biologic agent in Crohn’s disease is exciting, and in the coming years we look forward to seeing the role this agent plays in clinical practice,” remarked Dr Stuart Bloom, consultant gastroenterologist, University College London Hospitals.

Crohn’s disease is a chronic inflammatory bowel disease which affects up around 115,000 people in the UK and there is currently no known cure.

“Janssen is committed to delivering medicines for use in a variety of immunological conditions,” commented Dr Rozlyn Bekker, medical director of Janssen UK & Ireland. “The treatment options available in Crohn’s disease are currently limited and we are very pleased to announce the launch of ustekinumab in the UK, which offers an alternative mechanism of action for the treatment of those with this condition. The potential to offer sustained remission in Crohn’s disease indicates a step forward in the management of this chronic and debilitating illness.”

Matt Fellows

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