Johnson & Johnson’s streak of trial wins for its blockbuster drug Tremfya has come to an end.
The blockbuster drug failed in a Phase 2 test in adults with giant cell arteritis, an autoimmune condition in which inflammation hampers blood vessels and interrupts blood flow, a spokesperson for the pharmaceutical company confirmed to Endpoints News on Monday. The failure was first disclosed in an update to a federal clinical trials database.
J&J recently decided to “stop further development of guselkumab for the treatment of new-onset or relapsing giant cell arteritis based on insufficient efficacy findings,” the J&J spokesperson said in an emailed statement. The company said it had not identified any new safety concerns.
The disease has a smaller population than Tremfya’s approved indications of plaque psoriasis and active psoriatic arthritis. And the setback comes shortly after J&J reported positive readouts for the drug in ulcerative colitis and Crohn’s disease. The pharma giant filed for approval in ulcerative colitis in March and asked the FDA earlier this month for a Crohn’s label.
Tremfya is one of J&J’s top-selling medicines, bringing in approximately $3.1 billion in 2023 sales, up 18% from 2022.
Roche’s Actemra became the first FDA-approved drug for giant cell arteritis in 2017. Another blockbuster autoimmune treatment, AbbVie’s Rinvoq, cleared a Phase 3 trial earlier this year, likely setting up the JAK inhibitor for an expanded label. Meanwhile, Novartis’ Cosentyx is also in Phase 3 testing in the condition. The disease is more common in older adults and often presents initially as a headache, but can lead to vision issues or blindness if untreated, according to the American College of Rheumatology. Initial treatment is often with steroids.
J&J will “continue to consider the condition as we look at our other pipeline assets,” the spokesperson added. J&J has a broad pipeline of autoimmune drugs, with Stelara and Tremfya leading the pack and multiple experimental ones coming up, including Protagonist-licensed JNJ-2113, an oral IL-23 in Phase 3 for psoriasis. The New Jersey healthcare company also recently bagged two small startups in the autoimmune and immunology space, paying $850 million upfront for Proteologix and $1.25 billion for Yellow Jersey Therapeutics.