J&J Gains FDA Approval for Tremfya in IBD

The FDA has greenlit Johnson & Johnson's IL-23 inhibitor, Tremfya, for treating ulcerative colitis, marking a significant milestone for the pharmaceutical giant. This approval amplifies J&J's aspirations that Tremfya will emerge as a robust successor to its blockbuster drug, Stelara.

The recent label expansion marks the first instance of Tremfya being authorized to address a variant of inflammatory bowel disease. Previously, it was approved for conditions like plaque psoriasis and psoriatic arthritis. Additionally, applications have been filed with US regulators to use Tremfya for treating Crohn’s disease, among other medical conditions.

David Rubin, the principal investigator of Tremfya's Phase 2b/3 study and director of the Inflammatory Bowel Disease Center at the University of Chicago, highlighted the drug's effectiveness. "Treatment with Tremfya resulted in significant improvement in the chronic symptoms of ulcerative colitis, and importantly, normalization in the endoscopic appearance of the intestinal lining," Rubin stated.

As Tremfya stepped into 2024, it recorded impressive sales figures, garnering $3.15 billion globally in 2023, a 17.9% increase compared to the previous year. However, these numbers still lagged behind those of Stelara, J&J’s flagship IBD medication, which raked in almost $11 billion in 2023.

Stelara, though still a heavyweight, faces rising competition from biosimilars gaining traction among insurers. In the first six months of 2024, Stelara generated $5.3 billion in global sales, reflecting a modest 1.8% increase over the same period in 2023. Conversely, Tremfya exhibited a robust 27.3% growth in first-half revenue.

Despite the rapid rise of Tremfya within J&J’s immunology division, company executives seem equally enthusiastic, if not more so, about a forthcoming oral IL-23 inhibitor. CEO Joaquin Duato, speaking at an investor conference earlier in the month, described the entry of this new drug, designated JNJ-2113, as a “market-changing event.”

Duato projected that the new oral treatment could serve approximately 5 million patients who are currently not inclined towards injectable therapies. He emphasized that the market would be sufficiently large to accommodate both JNJ-2113 and Tremfya. He further noted that Tremfya's introduction into the inflammatory bowel disease space would act as a "major growth driver" for the company.