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J&J (JNJ) Stelara Gets Approval in EU for Label Expansion

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Johnson & Johnson’s (JNJ - Free Report) subsidiary, Janssen Therapeutics, announced that the European Commission (EC) has approved its prescription drug Stelara for the treatment of moderate-to-severely active Crohn’s disease in adults.

Stelara is presently marked in the EU and U.S. for the treatment of moderate-to-severe plaque psoriasis and active psoriatic arthritis.

The approval was not surprising as the European Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) had granted a positive opinion to Stelara, recommending approval for the indication in September. Also, in the same month, Stelara received the FDA approval for the same indication. J&J is also evaluating Stelara as a subcutaneous treatment for ulcerative colitis (phase III ongoing) and axial spondylytis (phase III).  

Sales of Stelara in the upcoming quarters should receive a boost with this label expansion. According to the company’s press release, more than five million people worldwide suffer from Crohn’s disease and ulcerative colitis which are collectively referred to as inflammatory bowel disease (IBD).

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Apart from Stelara, J&J is also working actively on expanding the label of other new marketed products like Simponi, Xarelto and Imbruvica. For Imbruvica (partner: AbbVie, Inc. (ABBV - Free Report) , six additional indications have been approved since its launch and the drug is also being evaluated in a number of combination therapies. For Xarelto, there are eight new indications seeking trials as part of the EXPLORER clinical development program. While Johnson & Johnson has exclusive U.S. marketing rights of Xarelto, the drug is being marketed by Bayer AG (BAYRY - Free Report) outside the U.S.

Simponi (partner: Merck & Co., Inc. (MRK - Free Report) received approval this year in the EU for the treatment of polyarticular juvenile idiopathic arthritis in combination with methotrexate. Also, the company plans to file two line extensions for Simponi Aria, the intravenous formulation of Simponi, in psoriatic arthritis and ankylosing spondylitis. We believe that in the forthcoming period, these drugs will contribute significantly to the company’s top line.

J&J 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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