J&J aims to extend Tremfya for two pediatric uses

Johnson & Johnson has submitted applications for two new pediatric uses of its successful immunotherapy, Tremfya, aiming to succeed its highly profitable drug Stelara. If these applications are approved, Tremfya would be used to treat children aged six and older with moderate-to-severe plaque psoriasis, and those aged five and older with active juvenile psoriatic arthritis.

Liza O’Dowd, J&J’s leader in immunodermatology, remarked in a statement that there is a significant lack of treatment options for children and adolescents suffering from these conditions. Many of these younger patients endure severe symptoms that impact their quality of life. She emphasized that this milestone highlights the company's dedication to revolutionizing care for patients of all ages and builds on its extensive knowledge and history in IL-23 and immune-mediated diseases.

Tremfya received its initial approval in 2017 for use in adults with plaque psoriasis. In 2023, the drug generated $3.1 billion in sales. Company executives are optimistic that Tremfya could eventually match or surpass the success of Stelara, which generated $10.9 billion in sales in the same year. Recently, Tremfya was approved in September to treat ulcerative colitis, marking its entry into the inflammatory bowel disease market, an important area for Stelara.

Stelara is already authorized to treat children aged six and older with moderate to severe plaque psoriasis or active psoriatic arthritis. However, the market for Stelara is expected to face competition from biosimilars starting in 2025. The most recent biosimilar to gain approval is Biocon Biologics’ Yesintek.

Jennifer Taubert, J&J’s executive vice president and worldwide chairman of innovative medicine, discussed the future prospects of Tremfya during the company's latest quarterly call in October. She indicated that considering Stelara's strong performance in treating inflammatory bowel disease and its potential, Tremfya is seen as an asset that could be as significant as, or even more substantial than, Stelara.

In summary, Johnson & Johnson is strategically positioning Tremfya to potentially take over and exceed Stelara's success by expanding its use to pediatric patients. This move underscores the company's ongoing commitment to addressing critical gaps in treatment for various age groups and maintaining its leadership in the field of immunotherapy and immune-mediated diseases.