Janssen's Guselkumab (Tremfya) Designated as Breakthrough Therapy in China for Moderately to Severely Active Crohn’s Disease

On February 27, the website of the Center for Drug Evaluation (CDE) under the China National Medical Products Administration (NMPA) announced that Johnson & Johnson's Guselkumab Injection is proposed to be included in the breakthrough therapy designation. The indication is: treatment of adult patients with moderately to severely active Crohn's disease (CD).

Guselkumab is the world's first approved interleukin-23 (IL-23) inhibitor, which can specifically target and inhibit IL-23, a cytokine that plays a critical role in autoimmune diseases.

Guselkumab was first approved for marketing in the United States on July 13, 2017, for adult patients with moderate to severe plaque psoriasis who are candidates for systemic therapy and phototherapy, under the trade name Tremfya; it was approved in Japan in November 2018 for the treatment of palmoplantar pustulosis; in July 2020, the FDA approved it for the treatment of active psoriatic arthritis. Guselkumab was approved for marketing in China on December 31, 2019, for the treatment of adult patients with moderate to severe plaque psoriasis.

In May 2022, Johnson & Johnson announced the latest data from the Phase II GALAXI 1 study of guselkumab in treating moderate to severe active Crohn's disease. The trial results showed that 47.5%-66.7% of subjects who had an inadequate response or were intolerant to conventional therapies and/or biologics achieved high-level clinical biomarker responses after 48 weeks of treatment with different doses of Tremfya. The proportion of patients achieving endoscopic response was 44.3%-46%. Additionally, the proportion of patients achieving clinical remission with C-reactive protein (CRP) ≤3mg/L or fecal calprotectin levels ≤250μg/g ranged between 39.3%-66.7%.

Tremfya, as the world's first approved IL-23 inhibitor, has become a blockbuster since its approval, with global sales reaching $2.668 billion in 2022, driven by its market performance in the fields of plaque psoriasis and psoriatic arthritis autoimmune diseases.

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