FDA Grants TREMFYA® Approval for Pediatric Psoriasis and Arthritis Treatment

FDA Approves TREMFYA® for Pediatric Use

The U.S. Food and Drug Administration (FDA) has made a groundbreaking move by approving TREMFYA® (guselkumab) for the treatment of moderate to severe plaque psoriasis and active psoriatic arthritis in pediatric patients aged six years and older. This historic approval marks TREMFYA® as the first and only IL-23 inhibitor approved for these specific pediatric conditions.

With approximately 20,000 children under ten diagnosed with plaque psoriasis annually and about 14,000 suffering from psoriatic arthritis, the approval delivers a significant treatment option for those affected. The disease can start in childhood, with about one-third of psoriasis cases beginning during these formative years. The visible symptoms of psoriasis, such as inflamed and scaly plaques, can be itchy or painful, often causing emotional distress for young patients, potentially impacting their long-term quality of life.

The FDA's approval stems from data obtained during the Phase 3 PROTOSTAR study, which demonstrated high levels of skin clearance in pediatric patients treated with TREMFYA® compared to those receiving a placebo. The study showed that 56% of patients given TREMFYA® achieved PASI 90, indicating significant skin improvement. Additionally, 66% of those treated reached high levels of skin clearance at Week 16, reinforcing the efficacy of TREMFYA® in pediatric applications.

Vimal Hasmukh Prajapati, M.D., a study investigator and Clinical Associate Professor at the University of Calgary, emphasized the urgent need for effective therapies for these debilitating immune-mediated diseases. He stated, "Despite advancements, there remains a significant gap in available treatments for pediatric psoriasis and psoriatic arthritis. The approval of TREMFYA offers a well-established option with proven safety and efficacy, significantly improving the quality of life for affected children."

In addition to the approval for moderate to severe plaque psoriasis, TREMFYA® also received clearance for children with active psoriatic arthritis aged six and older who meet specific weight criteria. This designation further bolsters the accessibility of treatment for a group that currently faces limited options.

Brandee Pappalardo, VP of Medical Affairs at Johnson & Johnson, remarked, "Every child deserves to embrace life without the discomfort of psoriasis or the restrictions of joint pain. This approval not only supports children but also their families and caregivers, reaffirming our commitment to exploring the full potential of TREMFYA for both pediatric and adult patients."

For treatment, TREMFYA® is administered as a subcutaneous injection—initially at Week 0, followed by additional doses at Week 4 and then every eight weeks thereafter. The recommended dosage for pediatric patients is 100 mg, delivered via a prefilled syringe.

Leah M. Howard, JD, President and CEO of the National Psoriasis Foundation, added her voice in support, emphasizing the emotional and physical impact of these conditions on children. "New treatment options like TREMFYA® can offer vital relief from the discomfort and stigma, allowing children to participate fully in life’s experiences."

Johnson & Johnson's continuous innovation in treating chronic immune-mediated diseases is demonstrated through this strategic progression, which echoes the company's commitment to improving health outcomes. Recently, the company has also expanded TREMFYA®'s indications for adult patients, reflecting a broader understanding of the drug's potential across various demographics. As it stands, TREMFYA® maintains marketing rights in numerous countries, including Europe and Japan, and serves as a beacon of hope for both healthcare providers and families navigating the complexities of psoriasis and psoriatic arthritis treatments today.

As we look to the future, ongoing research will further explore the long-term safety and effectiveness of TREMFYA®, ensuring that children and adults alike can benefit from this innovative therapy.