J&J expands Tremfya into IBD with new FDA approval

The FDA has approved Johnson & Johnson’s IL-23 blocker Tremfya to treat ulcerative colitis, a boost to the pharma’s hopes that the drug will serve as a worthy follow-up to the blockbuster Stelara.

Wednesday’s label expansion is the first time Tremfya has been given the go-ahead to treat a form of inflammatory bowel disease. Already approved for plaque psoriasis and psoriatic arthritis, it’s also been submitted to US regulators as a treatment for Crohn’s disease, among other indications.

“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,” said David Rubin, primary investigator of the drug’s Phase 2b/3 study and director of the Inflammatory Bowel Disease Center at the University of Chicago, in a statement.

The drug entered 2024 with the wind at its back, recording $3.15 billion in worldwide sales in 2023 — a 17.9% increase compared to the year prior. Those figures still lived in the shadow of Stelara, J&J’s blockbuster IBD med that brought in almost $11 billion in 2023.

Joaquin Duato

But Stelara biosimilars are gaining steam and insurers are elevating them. Through the first six months of 2024, Stelara brought in $5.3 billion in global sales, only a 1.8% increase versus the same period in 2023. Tremfya, on the other hand, reported a 27.3% growth in first-half revenue.

Despite Tremfya’s fast-rising ascent through J&J’s immunology portfolio, executives appear equally, if not more, excited about a late-stage oral IL-23 inhibitor. CEO Joaquin Duato said at an investor conference earlier this month that the entrance of that drug, called JNJ-2113, will be a “market-changing event.”

“We’ll see how the market pans out but there’s enough room today for patients that do not get into injectable therapy,” he said then, estimating that there will be about 5 million patients that could be served by a new oral option.

Duato emphasized that the market size will be plenty big to accomodate both JNJ-2113 and Tremfya, saying that Tremfya’s entrance into IBD will be a “major growth driver.”