Janssen’s Stelara approved in Europe for Crohn’s disease

Janssen has announced that its drug Stelara has been approved in Europe as a treatment for Crohn's disease.

The biologic drug has been approved by the European Commission for the treatment of adult patients with moderately to severely active Crohn's disease who are unable to benefit from conventional therapy or an anti-TNF.

It becomes the first biologic therapy for Crohn's disease that targets interleukin-12 and interleukin-23 cytokines, which are known to play a key role in inflammatory and immune responses.

This approval was based on data from three pivotal phase III trials including approximately 1,400 patients, showing that treatment with Stelara induced clinical response and maintained clinical remission in a significantly greater proportion of patients compared to placebo.

Jane Griffiths, chair of Janssen's Europe, Middle East and Africa business, said: "We are committed to working with health authorities across Europe to make it available as quickly as possible for those living with Crohn's disease."

Stelara is also approved for the treatment of plaque psoriasis in 87 countries, psoriatic arthritis in 71 countries and paediatric psoriasis in 34 countries.

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