The FDA has approved infliximab-dyyb (Zymfentra, Celltrion), the first subcutaneous formulation of infliximab to gain approval for the maintenance treatment of adults with moderately to severely active ulcerative colitis and Crohn’s disease.
Infliximab-dyyb is given following treatment with an infliximab product administered intravenously. It blocks the action of tumor necrosis factor-alpha.
The approval was based on phase 3 data from the LIBERTY-UC (ClinicalTrials.gov Identifier: