SPRING HOUSE, Pa. - Johnson & Johnson has filed for U.S. Food and Drug Administration (FDA) approval to use its drug TREMFYA® (guselkumab) in treating children with two specific conditions. The supplemental Biologics License Applications (sBLAs) seek to extend the use of TREMFYA® to children aged six and older with moderate-to-severe plaque psoriasis (PsO) and children aged five and above with active juvenile psoriatic arthritis (jPsA).
The applications are supported by data from a Phase 3 study, PROTOSTAR, which focused on pediatric patients with moderate to severe plaque PsO, and bridging pharmacokinetic data from adult studies. Additionally, the jPsA application includes PK extrapolation analyses from adult psoriatic arthritis (PsA) studies and safety data from the PROTOSTAR study. With annual revenues of $87.7 billion and a strong track record of dividend payments for 54 consecutive years, Johnson & Johnson demonstrates the financial stability needed to support its drug development pipeline.
TREMFYA® is a monoclonal antibody that targets the p19 subunit of IL-23, a cytokine involved in inflammatory diseases such as PsO and PsA. It is currently approved for use in adults with plaque psoriasis, psoriatic arthritis, and moderately to severely active ulcerative colitis. The drug's efficacy in adults has led to the submission for pediatric use, aiming to fill a treatment gap for children suffering from these conditions.
Plaque psoriasis can begin in childhood, affecting nearly 20,000 children under ten each year in the United States. Juvenile psoriatic arthritis is a chronic condition characterized by joint inflammation and psoriasis, comprising about 5% of the juvenile idiopathic arthritis population.
The FDA's decision on these applications will potentially expand treatment options for pediatric patients suffering from these chronic conditions. The company's commitment to addressing the needs of all age groups with immune-mediated diseases is evident in this move.
This news is based on a press release statement and does not include any promotional content. The information provided is subject to FDA review, and the outcomes of these applications are pending. For deeper insights into Johnson & Johnson's financial health and growth prospects, including exclusive Fair Value analysis and 8+ additional ProTips, visit InvestingPro, where you'll find comprehensive Pro Research Reports that transform complex Wall Street data into actionable intelligence.
In other recent news, Johnson & Johnson has made significant strides in the medical and pharmaceutical field. The company has submitted a supplemental Biologics License Application to the U.S. Food and Drug Administration for a new subcutaneous induction regimen of TREMFYA® for adults with moderately to severely active ulcerative colitis. Additionally, the FDA has awarded a second Breakthrough Therapy designation to nipocalimab for the treatment of Sjögren's disease.
Johnson & Johnson has also applied to the FDA and European Medicines Agency for a new indication of DARZALEX FASPRO® in the treatment of high-risk smoldering multiple myeloma. The company's Phase 3 GRAVITI study of TREMFYA® has shown promise in treating Crohn's disease. Amid these developments, Johnson & Johnson reported a robust Q3 result with operational sales growth of 6.3%, reaching $22.5 billion.
Recent news also includes analyst upgrades from RBC Capital Markets and Stifel Financial (NYSE:SF) following the company's strong financial performance. However, the company faces legal challenges, including a recent order to pay $15 million in a talc cancer case. These recent developments highlight Johnson & Johnson's diverse operational activities and potential growth areas.
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