Celltrion USA launches ZYMFENTRA for ulcerative colitis and Crohn’s disease

In a significant advancement for patients with digestive disorders, Celltrion USA has announced the availability of ZYMFENTRA (infliximab-dyyb), marking it as the first and only subcutaneous formulation of infliximab approved by the U.S. Food and Drug Administration (FDA) in 2023. This revolutionary treatment offers a new hope and convenience for adults suffering from moderately to severely active ulcerative colitis (UC) or Crohn’s disease (CD), following an initial induction treatment with an intravenous infliximab product. ZYMFENTRA is administered as a 120 mg dose every two weeks, providing a significant leap in the maintenance therapy of these conditions.

The approval of ZYMFENTRA is a culmination of rigorous clinical research, notably the phase III LIBERTY-UC and LIBERTY-CD studies. These pivotal trials demonstrated ZYMFENTRA’s superiority in achieving clinical remission and endoscopic response over placebo, offering a promising maintenance treatment option for patients with UC and CD. The safety profile of ZYMFENTRA was comparable to that of the placebo during the maintenance phase, with no new safety concerns identified, offering reassurance to both patients and healthcare providers.

Thomas Nusbickel, Chief Commercial Officer at Celltrion USA, emphasized the significance of this breakthrough, stating, “Infliximab is a well-established treatment for people living with ulcerative colitis or Crohn’s disease. The novel subcutaneous administration represents an important advancement in patient care that can offer a convenient treatment option, allowing patients in the U.S. to have greater flexibility in managing their disease.”

The introduction of ZYMFENTRA has been met with enthusiasm from the medical community and patient advocacy groups alike. Michael Osso, President and CEO of the Crohn’s & Colitis Foundation, highlighted the profound impact of this advancement, noting that it offers “meaningful advancement for eligible adult patients with Crohn’s disease and ulcerative colitis, who now have more options and can receive treatment of ZYMFENTRA at home, through subcutaneous delivery, allowing more flexibility and choice.”

Dr. Jean-Frederic Colombel from the Icahn School of Medicine at Mount Sinai further underscored the value of ZYMFENTRA in providing patients with enhanced control over their treatment, citing the flexibility and convenience afforded by the subcutaneous administration method.

With patent protection extending through 2037 for its dosage form and until 2040 for its route of administration, ZYMFENTRA stands as a testament to Celltrion USA’s commitment to innovation and patient care in the treatment of chronic inflammatory conditions. This landmark approval paves the way for a new era in the management of ulcerative colitis and Crohn’s disease, offering a lifeline to those in search of effective and convenient treatment options.