By | March 18, 2024

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Celltrion USA announced the availability of ZYMFENTRA™ (infliximab-dyyb), the first FDA-approved subcutaneous infliximab for the treatment of moderately to severely active ulcerative colitis and Crohn’s disease. ZYMFENTRA is now commercially available across the U.S. starting March 15, 2024.
Thomas Nusbickel, Chief Commercial Officer at Celltrion USA, highlighted the significance of ZYMFENTRA’s novel subcutaneous administration, offering a convenient treatment option for patients with ulcerative colitis and Crohn’s disease. The approval of ZYMFENTRA was based on phase III pivotal data from the LIBERTY-UC and LIBERTY-CD studies, showing its superiority in clinical remission and endoscopic response compared to placebo.
Michael Osso, President and CEO of the Crohn’s & Colitis Foundation, emphasized the importance of ZYMFENTRA’s availability for eligible adult patients, providing more options and flexibility in managing their conditions. Dr. Jean-Frederic Colombel of Icahn School of Medicine at Mount Sinai also praised ZYMFENTRA for offering patients better control of their treatment.
ZYMFENTRA is a subcutaneous injection used for the maintenance treatment of moderately to severely active ulcerative colitis and Crohn’s disease in adults. It blocks the action of tumor necrosis factor-alpha, a protein that can trigger immune system attacks on healthy tissues.
However, it is essential to note the important safety information associated with ZYMFENTRA. Patients may be at an increased risk of developing serious infections, including tuberculosis and invasive fungal infections. The risks and benefits of treatment with ZYMFENTRA should be carefully considered, especially in patients with chronic or recurrent infections.
Malignancies, including lymphomas, have been reported in children, adolescents, and young adults treated with TNF blockers like ZYMFENTRA. Close monitoring and evaluation are crucial for patients receiving this treatment to mitigate potential risks.
In conclusion, the availability of ZYMFENTRA as a subcutaneous infliximab presents a significant advancement in the treatment of ulcerative colitis and Crohn’s disease. Patients now have a more convenient and flexible option for managing their conditions, with the added benefit of being able to receive treatment at home. It is important for healthcare professionals and patients to weigh the benefits and risks of ZYMFENTRA to ensure safe and effective treatment outcomes.

[4] Celltrion Data on File