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Janssen Gets CHMP Positive Opinion For Stelara - Quick Facts

Janssen Pharmaceutical Companies of Johnson & Johnson (JNJ) said that that the European Medicines Agency's Committee for Medicinal Products for Human Use or CHMP has adopted a positive opinion recommending Stelara or ustekinumab's marketing authorization in the European Union for the treatment of adult patients with moderately to severely active ulcerative colitis or UC.

The treatment is recommended for patients who have inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic or have medical contraindications to such therapies.

The CHMP's positive opinion is based on data from the pivotal Phase 3 UNIFI trial program that demonstrated ustekinumab's efficacy as a treatment option for patients with moderately to severely active UC.

If approved, ustekinumab will be the first interleukin or IL-12/23 inhibitor licensed for ulcerative colitis.

UC is a serious and chronic immune-mediated inflammatory disease of the large intestine, affecting 2.6 million people in Europe, for which there is currently no cure.

Symptoms vary but may include abdominal cramps, bloody diarrhoea and fatigue. For up to two thirds of people with UC, current treatments are not completely successful or complications may arise.

Janssen noted that following this positive CHMP opinion, it expects a final decision from the European Commission regarding its marketing authorization later this year.

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