Janssen Scores FDA Approval for Tremfya as First Dual-Formulation IL-23 Inhibitor in Crohn’s Disease

The U.S. Food and Drug Administration (FDA) announced on March 21 the approval of Johnson & Johnson's Tremfya (guselkumab) for the treatment of adult patients with moderately to severely active Crohn’s disease. This approval means that Tremfya has become the first interleukin-23 (IL-23) inhibitor that can be administered via both intravenous and subcutaneous injection for this indication, providing more flexible treatment options for patients with Crohn’s disease.

The significant strategic importance of Johnson & Johnson's recent approval lies in the potential for Tremfya to become the successor to its blockbuster drug Stelara (ustekinumab). As a biologic targeting IL-12/IL-23, Stelara has generated cumulative global sales exceeding $100 billion since its launch in 2009. However, starting from January 2025, the U.S. market will see the arrival of the first four biosimilars to Stelara, including Amgen's Wezlana, Teva and Alvotech’s jointly launched Selarsdi, Sandoz's Pyzchiva, and Biocon’s Yesintek.

More challenging is that Cigna Evernorth, a large U.S. insurance company, announced as early as September 2024 that it would launch a zero-copay biosimilar to Stelara in 2025. These moves put Stelara's market share at significant risk of erosion.

The expansion of Tremfya's indications is based on the results of multiple Phase III clinical trials. These trials included more than 1,300 Crohn's disease patients who were unresponsive or intolerant to conventional treatments (such as corticosteroids, immunomodulators) or other biologics.

In the GRAVITI study, patients treated with subcutaneous injection of Tremfya showed significantly higher clinical remission rates and endoscopic response rates compared to the placebo group. In the GALAXI study, Tremfya outperformed Stelara across all composite endoscopic endpoints, becoming the first IL-23 inhibitor to defeat this blockbuster drug in a double-blind pivotal trial.

Chris Gasink, Vice President of Medical Affairs for Gastroenterology and Autoantibodies at Johnson & Johnson, stated, "This approval not only provides patients with a new and effective treatment option but also allows them the flexibility to self-administer from the start of treatment." Currently, Johnson & Johnson is actively seeking approval for the subcutaneous injection formulation of Tremfya for the treatment of ulcerative colitis.

Besides Tremfya, Johnson & Johnson has made other significant advancements in the immunology field. Earlier this month, the company announced the Phase III clinical trial results of its oral IL-23 receptor blocker icotrokinra. The data showed that icotrokinra was more effective than Bristol Myers Squibb's Sotyktu (deucravacitinib) in treating plaque psoriasis. Johnson & Johnson believes that icotrokinra has the potential to become the "new standard of care" for this indication.

Tremfya was first approved in 2017 for the treatment of moderate to severe plaque psoriasis, and subsequently received indications for psoriatic arthritis and ulcerative colitis. Its mechanism of action involves targeting the IL-23 cytokine, blocking its interaction with the receptor, thereby inhibiting the release of pro-inflammatory factors and reducing the inflammatory response in immune-mediated diseases.

The breakthrough of Tremfya in the Crohn's disease field further solidifies Johnson & Johnson's leadership position in the treatment of immune diseases. As competition from biosimilars intensifies, the performance of Tremfya and its pipeline products will be key to Johnson & Johnson maintaining its market share.

The expansion of Tremfya's indications comes at a time when biosimilars are accelerating their penetration in the U.S. market. For originator drug manufacturers, extending the product lifecycle through innovation and indication expansion has become crucial. Tremfya's success in the Crohn's disease field provides strong support for Johnson & Johnson in addressing competition faced by Stelara, while also laying a solid foundation for its long-term development in the field of immune disease treatment. In the future, with the launch of more biosimilars and adjustments to medical insurance policies, the market landscape may undergo further changes.