#United States #TREMFYA® #Johnson & Johnson #Horsham #Psoriatic Arthritis

Johnson & Johnson Makes Significant Move for TREMFYA®

Johnson & Johnson (NYSE: JNJ) has taken a significant step in advancing treatment for active psoriatic arthritis (PsA) by submitting a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA). This application seeks approval to modify the TREMFYA® (guselkumab) label, indicating its ability to inhibit the progression of structural joint damage—a claim supported by new evidence from the Phase 3b APEX study.

APEX Study Results

The Phase 3b APEX study focused on adults with active psoriatic arthritis, demonstrating that TREMFYA® not only meets its primary endpoint of reducing joint symptoms but also inhibits the progression of structural damage, as measured by the modified van der Heijde-Sharp (vdH-S) score. After 24 weeks, results indicated significant improvements compared to placebo among bio-naïve participants—to be showcased at the forthcoming European Alliance of Associations for Rheumatology (EULAR) 2025 Congress.

Brandee Pappalardo, Ph.D., M.P.H., Vice President of Medical Affairs for Dermatology and Rheumatology at Johnson & Johnson, emphasized the need for advanced therapies to address the long-term implications of PsA. "Psoriatic arthritis is a complex disease that can lead to severe joint damage, making it essential to develop innovative treatments to manage both the symptoms and the long-term progress of the condition," she stated.

Unique Position in the Market

With this new evidence, TREMFYA® aims to be recognized as the first and only IL-23 inhibitor that not only offers symptom relief but also significantly curtails the progression of joint damage in patients suffering from active PsA. It distinguishes itself as a dual-acting monoclonal antibody, blocking IL-23 and simultaneously binding to the receptor CD64, enhancing its therapeutic potential.

The data from the APEX study align with the established safety profile of TREMFYA®, which has reassured healthcare providers about its use in treatment. Additional findings and insights are expected to be disclosed in future medical gatherings.

About Psoriatic Arthritis

Psoriatic arthritis affects nearly half of patients with psoriasis and is a chronic inflammatory condition characterized by ongoing pain, joint stiffness, and swelling, which can seriously affect patients' quality of life. Most commonly diagnosed in individuals aged between 30 and 50, this debilitating disease brings along comorbidities like fatigue, obesity, and mental health issues, further complicating management and treatment strategies.

Comprehensive Treatment Options

TREMFYA® is currently approved in the U.S. for various indications including moderate to severe plaque psoriasis and active psoriatic arthritis. Its approval spans other countries such as Europe, Canada, and Japan as well. Johnson & Johnson retains the exclusive global marketing rights for TREMFYA®, positioning itself as a leader in the treatment of immune-mediated diseases.

Patients aiming for better management of psoriatic arthritis symptoms may find great relief with TREMFYA®, which promises to address not just the immediate impacts of the condition but also its long-term consequences.

For further information, patients and healthcare professionals can explore more about TREMFYA® at www.tremfya.com.

Important Safety Information

While TREMFYA® offers promising benefits, patients should be aware of possible side effects, including serious allergic reactions and infections. Prior screenings for tuberculosis and infections are essential before starting treatment. Patients must consult their healthcare provider for a comprehensive understanding of the medication and its implications.

In conclusion, Johnson & Johnson's proactive approach not only highlights its commitment to innovation in the treatment of significant health challenges but also reinforces the need for effective solutions to improve the quality of life for those affected by psoriatic arthritis.