The U.S. Food and Drug Administration (FDA) recently approved Tremfya, a new prefilled pen injector. It is indicated for the treatment of moderate to severe, fistulizing forms of Crohn’s disease. Approved on March 24, 2025, Tremfya provides an option for patients and their caregivers to self-administer the treatment at home. This approval marks a significant advancement in managing Crohn's disease, which affects approximately three million people in the United States.
Tremfya works to inhibit a protein called interleukin-23 (IL-23). This protein is a key player in the development of Crohn’s disease. Tremfya, an IL-23 drug, works to actively reduce inflammation by blocking this protein. In fact, it produces relief more quickly and completely than all other treatments. As Tremfya binds indiscriminately to all CD64+ cells, this further improves its overall therapeutic effectiveness.
Prior to this, Tremfya was approved for psoriatic arthritis in July 2020 and ulcerative colitis in September. Its expansion of use to Crohn’s disease emphasizes this potential for treating other inflammatory conditions. Tremfya’s approval is a positive step forward to provide patients with more flexible and convenient treatment options.
"The fully subcutaneous regimen offers choice and flexibility for patients and providers that have not been available before." – Remo Panaccione, MD
The newly approved at-home injectable formulation of Tremfya provides an added opportunity for patients to assume more control over their care. Today, they can make their health easier to control like never before. This expansion removes a significant burden of having to continually go into a hospital for treatment.
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