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J&J's Stelara Gets EU Nod for Plaque Psoriasis in Children

Zacks Equity Research

Johnson & Johnson JNJ announced that the European Commission (EC) has approved the label expansion of Stelara (ustekinumab) for the treatment of moderate-to-severe plaque psoriasis in pediatric patients aged between six and 11 years for whom there are limited biologic treatment options.

Notably, in December 2019, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) rendered a positive opinion recommending the marketing approval of Stelara to treat the above-mentioned patient population.

With the latest nod in the EU, Stelara becomes the first available biologic treatment to deal with the given patient population to selectively address the IL-23/IL-12 pathway, an important therapeutic target for the given condition.

The EC’s approval for plaque psoriasis in pediatric patients was based on data from the phase III CADMUS Jr study. Results from the same showed that treatment with Stelara led to improved signs and symptoms of plaque psoriasis as well as better health-related quality of life in children aged from six to 11 years, who are living with this chronic disease.Stelara is also under the FDA review for plaque psoriasis in pediatric patients.

Shares of J&J have increased 15.8% in the past year compared with the industry’s rally of 17.4%.

Stelara is already approved to treat plaque psoriasis in adolescent and adult patients with plaque psoriasis, aged 12 years and above. This apart, the drug is marketed for active ulcerative colitis, psoriatic arthritis and moderate-to-severe Crohn's disease for adult patients in both the United States and the EU. The drug is also being studied for axial spondylitis in phase III studies.

Notably, in the fourth quarter of 2019, Stelara generated sales of $1.7 billion, reflecting a year-over-year rise of 17.7%, driven primarily by the Crohn's disease indication.

Continuous label expansion of the drug is not only expanding its eligible patient base but also contributing significantly to the company’s top line.

Zacks Rank & Other Stocks to Consider

J&J currently carries a Zacks Rank #2 (Buy). Other stocks worth considering in the large cap pharma sector include Roche Holding AG RHHBY, Eli Lilly and Company LLY and Bristol-Myers Squibb Company BMY, all carrying a Zacks Rank of 2. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Roche’s earnings estimates have moved 1.5% north for 2020 over the past 60 days. The stock has rallied 32.2% in the past year.

Eli Lilly’s earnings estimates have been revised 3.2% upward for 2020 over the past 60 days. The stock has jumped 22.8% in the past year.

Bristol-Myers earnings estimates have moved 2.8% north for 2020 over the past 60 days. The stock has surged 36.7% in the past year.

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