J&J’s Tremfya gets FDA approval for SC induction in active UC

Tremfya is a fully-human, dual-acting monoclonal antibody that works by selectively targeting IL-23, a protein involved in abnormal immune activity.

The drug is already approved in the US for the treatment of moderate to severe plaque psoriasis and active psoriatic arthritis, with a patient-controlled injector.

It was approved by the FDA for intravenous (IV) induction in UC last year and for both SC and IV induction in Crohn’s disease in March this year.

With the current FDA approval, Tremfya becomes the first and only IL-23 inhibitor offering both SC and IV induction options for treating UC and Crohn’s disease.

It is the first approved human dual-acting monoclonal antibody that inhibits IL-23 while binding to the CD64 receptor on cells producing IL-23, said the US drugmaker.

J&J innovative medicine gastroenterology and autoantibody medical affairs vice president Chris Gasink said: “With today’s approval, Tremfya is the first and only IL-23 inhibitor to offer inflammatory bowel disease patients robust clinical and endoscopic results with a fully subcutaneous regimen, now across both ulcerative colitis and Crohn’s disease.

“The initiation of a head-to-head study in Crohn’s disease is a further testament to our commitment to advancing the clinical evidence of Tremfya in IBD.”

The FDA approval was based on the results of the Phase III ASTRO trial.

In the trial, Tremfya showed statistically significant improvements in primary and secondary endpoints compared to placebo.

By week 12, 26% patients on Tremfya achieved clinical remission compared to 7% on placebo, and 36% achieved endoscopic improvement compared to 12%.

The trial’s results were consistent with the previously approved 200mg IV induction regimen, showing similar efficacy in clinical remission and endoscopic improvement.

Also, Tremfya SC induction followed by SC maintenance showed significant improvements in clinical outcomes by Week 24.

Furthermore, J&J announced a support programme, TREMFYA withMe, for commercially insured patients to potentially commence treatment within 24 hours.

Study investigator David Rubin said: “Historically, IL-23 inhibitors have required IV infusions at the start of therapy, which can create barriers to starting treatment or be burdensome for some patients and clinicians.

“With today’s approval, UC patients and providers now have the choice of starting Tremfya with a self-administered subcutaneous injection, with the same efficacy and safety that were established with IV induction in the prior clinical trials and subsequently seen in our real-world practice.”