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J&J's Stelara Gets Approval in EU for Ulcerative Colitis

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Johnson & Johnson JNJ announced that the European Commission (EC) has approved the label expansion of Stelara (ustekinumab) for the treatment of adults with moderately-to-severely active ulcerative colitis (UC). With the latest approval in EU, Stelara can now be prescribed to treat UC patients who have had an inadequate response to or were intolerant to either conventional therapy or a biologic or have medical contraindications to such therapies.

Stelara is also under review in the United States for the same indication.

Notably, Stelara, presently, has the approval to treat plaque psoriasis, psoriatic arthritis, and  moderate-to-severe Crohn's disease in both the United States and EU. 

The EC’s approval for UC is based on data from the pivotal phase III UNIFI study. The study was divided into an initial Induction study (UNIFI-I) of at least eight weeks, followed by a Maintenance study (UNIFI-M) of 44 weeks. Both studies demonstrated ustekinumab’s efficacy as a treatment for UC.

Ulcerative colitis or UC is a complicated immune disease in which patients suffer from persistent diarrhea, abdominal pain, blood in stool, loss of appetite, weight loss and fatigue. More than half of UC patients fail to achieve remission with the currently-available conventional or biologic therapies. The successful induction data from the UNIFI study highlights the potential of Stelara for them.

The stock has rallied 2%, so far this year, compared with the 3.3% increase recorded by the industry.

Sales of Stelara, one of the key drugs of J&J, grew 23.3% in the first half of 2019. The drug has been gaining market share, particularly owing to the uptick in Crohn's disease, the approval for the treatment of which was received both in the United States and the EU in 2016.

Other marketed UC treatments include Pfizer’s PFE JAK inhibitor, Xeljanz, and AbbVie’s ABBV Humira. Another company, Lilly LLY, is developing mirikizumab which is in late stage studies for the treatment of UC.

J&J currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.


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