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HORSHAM, Pa. - Johnson & Johnson (NYSE:JNJ) has submitted a supplemental Biologics License Application to the U.S. Food and Drug Administration seeking to include new evidence in the Tremfya (guselkumab) label regarding inhibition of structural damage progression in adults with active psoriatic arthritis.
The submission is supported by 24-week results from the Phase 3b APEX study, which demonstrated that Tremfya achieved both its primary endpoint of reducing joint symptoms and its major secondary endpoint of inhibiting progression of structural damage compared to placebo in bio-naïve patients. This development comes as JNJ continues to demonstrate strong market performance, with annual revenues reaching $90.6 billion in the last twelve months.
"Psoriatic arthritis is a complex disease that can lead to severe and irreversible joint damage," said Brandee Pappalardo, Vice President, Medical Affairs, Dermatology & Rheumatology at Johnson & Johnson Innovative Medicine, according to the press release.
Tremfya is the first and only fully-human monoclonal antibody approved for psoriatic arthritis that blocks IL-23 while also binding to CD64, a receptor on cells that produce IL-23. The medication is currently approved in the U.S. to treat adults with moderate to severe plaque psoriasis, active psoriatic arthritis, moderately to severely active ulcerative colitis, and moderately to severely active Crohn’s disease.
The APEX study data were consistent with Tremfya’s established safety profile, with additional data expected to be presented at future medical meetings.
Psoriatic arthritis is a chronic, immune-mediated inflammatory disease characterized by joint inflammation, pain, stiffness and swelling. It affects approximately 30% of people with plaque psoriasis and typically appears between ages 30 and 50. With JNJ trading near its 52-week high and showing slight undervaluation according to InvestingPro Fair Value metrics, investors can access detailed analysis and 10 additional ProTips about JNJ’s market position and growth potential through the comprehensive Pro Research Report, available exclusively to subscribers.
In other recent news, Johnson & Johnson reported strong financial performance, exceeding expectations in its second-quarter results. RBC Capital highlighted the company’s adjusted operational sales growth of 3.0% year-over-year, surpassing their estimate of 1.0%, leading them to raise their price target from $181 to $185. UBS also increased its price target for Johnson & Johnson, setting it at $190, citing robust sales growth in the company’s innovative medicines portfolio. Additionally, Erste Group upgraded Johnson & Johnson’s stock rating from Hold to Buy, noting higher operating margins and return on equity compared to competitors.
In regulatory developments, the European Commission approved Johnson & Johnson’s Darzalex subcutaneous formulation for adults with high-risk smoldering multiple myeloma, marking the first approved treatment for this patient group. Furthermore, the company has submitted a New Drug Application to the U.S. FDA for icotrokinra, a novel oral peptide for treating moderate to severe plaque psoriasis in patients aged 12 and older. The application is supported by successful data from four Phase 3 clinical trials demonstrating significant skin clearance. These developments reflect Johnson & Johnson’s ongoing efforts to expand its treatment portfolio and address unmet medical needs.
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