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J&J Files sBLA for Plaque Psoriasis in Adolescent Patients
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Johnson & Johnson’s (JNJ - Free Report) subsidiary, Janssen Therapeutics announced that it has submitted a Supplemental Biologics License Application (sBLA) to the FDA seeking approval of its prescription drug, Stelara for treatment of adolescent patients.
J&J’s share price has gained 0.8% in the past one month, underperforming the 1.3% gain witnessed by the Zacks classified Large-Cap Pharmaceuticals industry.
Stelara, the drug is presently marked in the EU and U.S. for the treatment of moderate-to-severe plaque psoriasis and active psoriatic arthritis in adults. The company is looking to get the drug approved for the treatment of adolescents (12 to 17 years of age) with moderate to severe plaque psoriasis.
According to the company’s press release, about 7.5 million people in America suffer from psoriasis with its intensity ranging from mild to severe and disabling. Moreover, about one third of those who develop the disease are below 20 years of age. Therefore, if approved for the adolescent patient population, the drug can address a significantly larger market.
The sBLA was supported by data from the phase III CADMUS registration study. The study assessed the efficacy and safety of Stelara in the treatment of adolescents (12 to 17 years of age) with moderate to severe plaque psoriasis. A phase III CADMUS Jr, is also ongoing to evaluate the efficacy and safety of Stelara in the treatment of pediatric patients (6 to 11 years of age). In November 2016, Stelara received approval in EU for the treatment of moderate-to-severely active Crohn’s disease in adults.
Further, J&J is evaluating Stelara in phase III studies as a subcutaneous treatment for ulcerative colitis and axial spondylytis.
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 J&J 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. Additionally, 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 these drugs will contribute significantly to the company’s top-line going forward.
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J&J Files sBLA for Plaque Psoriasis in Adolescent Patients
Johnson & Johnson’s (JNJ - Free Report) subsidiary, Janssen Therapeutics announced that it has submitted a Supplemental Biologics License Application (sBLA) to the FDA seeking approval of its prescription drug, Stelara for treatment of adolescent patients.
J&J’s share price has gained 0.8% in the past one month, underperforming the 1.3% gain witnessed by the Zacks classified Large-Cap Pharmaceuticals industry.
Stelara, the drug is presently marked in the EU and U.S. for the treatment of moderate-to-severe plaque psoriasis and active psoriatic arthritis in adults. The company is looking to get the drug approved for the treatment of adolescents (12 to 17 years of age) with moderate to severe plaque psoriasis.
According to the company’s press release, about 7.5 million people in America suffer from psoriasis with its intensity ranging from mild to severe and disabling. Moreover, about one third of those who develop the disease are below 20 years of age. Therefore, if approved for the adolescent patient population, the drug can address a significantly larger market.
The sBLA was supported by data from the phase III CADMUS registration study. The study assessed the efficacy and safety of Stelara in the treatment of adolescents (12 to 17 years of age) with moderate to severe plaque psoriasis. A phase III CADMUS Jr, is also ongoing to evaluate the efficacy and safety of Stelara in the treatment of pediatric patients (6 to 11 years of age). In November 2016, Stelara received approval in EU for the treatment of moderate-to-severely active Crohn’s disease in adults.
Further, J&J is evaluating Stelara in phase III studies as a subcutaneous treatment for ulcerative colitis and axial spondylytis.
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 J&J 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. Additionally, 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 these drugs will contribute significantly to the company’s top-line going forward.
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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Today, you are invited to download the full list of 220 Zacks Rank #1 "Strong Buy" stocks – absolutely free of charge. Since 1988, Zacks Rank #1 stocks have nearly tripled the market, with average gains of +26% per year. Plus, you can access the list of portfolio-killing Zacks Rank #5 "Strong Sells" and other private research. See these stocks free >>