J&J's subcutaneous version of Tremfya excels in Crohn's disease study

2024-06-20

临床结果上市批准临床3期免疫疗法

J&J's subcutaneous version of Tremfya excels in Crohn's disease study

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来源: FiercePharma

Tremfya's expansion comes as Johnson & Johnson prepares to lose exclusivity on its immunology stalwart Stelara.

In May, Johnson & Johnson touted the success of its intravenous (IV) formulation of Tremfya in two head-to-head trials against its own Stelara in Crohn’s disease. A month later, a subcutaneous (SC) version of Tremfya has excelled as an induction therapy in a phase 3 Crohn’s disease study.

In the GRAVITI trial, Tremfya met both co-primary endpoints, delivering a statically significant improvement versus placebo at week 12 for both remission and endoscopic response.

With the results of the three studies, Tremfya has shown its potential to become to the first IL-23 inhibitor IL-23 inhibitor to offer two induction options for Crohn’s disease, J&J said in a press release.

“Having both SC and IV induction options provides choice and versatility for patients and providers,” David Lee, M.D., Ph.D., J&J’s global therapeutic head immunology, said in a release. “Tremfya is poised to be the only IL-23 inhibitor IL-23 inhibitor to offer a full SC therapy for both induction and maintenance in Crohn’s disease.”

J&J plans to present the full trial data at upcoming medical meetings and will share the results with regulators, the company said.

The GRAVITI study evaluated Tremfya SC induction therapy in patients with moderate to severe Crohn’s who experienced an inadequate response or failed to tolerate conventional treatments (corticosteroids or immunomodulators) or biologic drugs (TNF agonists TNF agonists or Takeda’s Entyvio).

In addition to achieving its primary endpoints, GRAVITI reached statistical significance compared to placebo in all secondary objectives, J&J said. The secondary trial measures looked at remission and response rates at various time points, plus the rates of adverse events leading to treatment discontinuation, according to clinicaltrials.gov.

In 2022, AbbVie’s Skyrizi was the first IL-23 inhibitor IL-23 inhibitor approved to treat Crohn’s. Then last year, it topped J&J’s Stelara in its own head-to-head study, facilitating remission in 61% of patients at week 48 versus 41% for Stelara.

Tremfya is one of J&J’s most important medicines. It was approved for plaque psoriasis in 2017 and added a psoriatic arthritis nod in 2020. In March of this year, J&J submitted for approval for Tremfya to treat ulcerative colitis. It generated sales of $3.1 billion in 2023, which was an increase of 18% from the previous year.

Tremfya’s emergence is timely as J&J is girding for the loss of exclusivity of Stelara, which accounted for $10.9 billion in sales in 2023, which was 13% of the company’s total revenue. Stelara biosimilars are on their way this year in Europe and U.S. copycats are expected to be available early next year.

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