FDA Approves Johnson & Johnson's Tremfya for Crohn’s Disease

Johnson & Johnson (J&J) has received approval from the US Food and Drug Administration (FDA) for Tremfya (guselkumab) to be used in the treatment of adults with moderately to severely active Crohn’s disease (CD). CD is among the primary types of inflammatory bowel disease (IBD), affecting approximately three million individuals in the United States. The condition is characterized by a range of symptoms, including abdominal pain, frequent diarrhea, rectal bleeding, unintended weight loss, and fever.

Tremfya offers patients both subcutaneous and intravenous induction options, providing a versatile approach to managing CD. The drug works by blocking interleukin-23 (IL-23), a key contributor to immune-mediated diseases, and binds to CD64, a receptor on cells responsible for producing IL-23. This dual approach aims to tackle the underlying mechanisms of CD, potentially improving patient outcomes.

Chris Gasink, Vice President of Medical Affairs, Gastroenterology, and Autoantibody at J&J Innovative Medicine, emphasized that Tremfya is unique as it is the first IL-23 inhibitor to offer a fully subcutaneous treatment option for moderate to severe CD. Gasink highlighted the significance of this approval, stating that it allows patients to achieve substantial progress in both clinical and endoscopic outcomes, with the added convenience of self-administration right from the start.

Tremfya is not new to the market; it is already approved in the United States for treating ulcerative colitis, another major form of IBD, as well as conditions like plaque psoriasis and psoriatic arthritis. The FDA's recent approval is backed by data from several phase 3 clinical trials, which included over 1,300 patients with moderate to severe CD who had either not responded to conventional therapy or biologics or were intolerant to them. These trials, particularly the GRAVITI program, demonstrated Tremfya's superiority over another J&J product, Stelara (ustekinumab), in all pooled endoscopic endpoints.

Remo Panaccione, the lead investigator of the phase 3 GRAVITI study from the University of Calgary, remarked on the ongoing challenges in managing CD. He noted that despite advancements, many patients continue to suffer from severe symptoms and require more effective treatment options. Panaccione expressed optimism about Tremfya’s approval, highlighting its robust effectiveness in achieving endoscopic remission with both subcutaneous and intravenous induction regimens. He underscored the importance of offering patients and healthcare providers new choices and flexibility that were previously unavailable.

This approval comes shortly after another significant milestone for J&J—just two weeks prior, J&J's Lazcluze (lazertinib) was approved by the Medicines and Healthcare Products Regulatory Agency as part of a combination therapy for certain lung cancer patients. This series of approvals underscores J&J's ongoing commitment to addressing complex medical conditions and providing innovative treatment options to enhance patient care.