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: NCT04205643) and LIBERTY-CD (ClinicalTrials.gov Identifier: NCT03945019) randomized, placebo-controlled clinical trials. The trials included 438 and 343 patients, respectively, and evaluated the drug’s effect on clinical remission: an absolute Crohn’s Disease Activity Index score of less than 150 points. 

At week 54, the rate of clinical remission was significantly greater in patients who received infliximab-dyyb (43.2% and 62.3%, respectively) than in those who received placebo (20.8% and 32.1%, respectively; P<0.0001).

The safety profile of infliximab-dyyb during the maintenance period was generally comparable between the treatment and placebo arms. The most common adverse events (≥3%) in each group were:

• Ulcerative colitis: COVID-19, anemia, arthralgia, injection site reaction, increased alanine aminotransferase and abdominal pain. 
• Crohn’s disease: COVID-19, headache, upper respiratory tract infection, injection site reaction, diarrhea, increased blood creatine phosphokinase, arthralgia, increased alanine aminotransferase, hypertension, urinary tract infection, neutropenia, dizziness and leukopenia. 

The prescribing information for infliximab-dyyb contains a boxed warning for serious infections—including tuberculosis, bacterial sepsis and invasive fungal infections—and malignancy. Lymphomas and other malignancies have been reported in patients treated with tumor necrosis factor blockers, including infliximab products. Additional warnings and precautions in the prescribing information concern hepatitis B virus reactivation, hepatotoxicity, congestive heart failure, hematologic reactions, hypersensitivity and other administration reactions, neurologic reactions, risk for additive immunosuppressive effects from prior biological products, autoimmunity, and vaccinations and use of live vaccines.

The full prescribing information for infliximab-dyyb can be found here.

“I am excited to see further data that validate a convenient treatment option that could allow more patients in the U.S. to have greater control of their disease management,” Jean-Frederic Colombel, MD, a gastroenterologist at Icahn School of Medicine at Mount Sinai, in New York City, commented in a press release from Celltrion.

—GEN Staff

Based on a press release.

Originally published by our sister publication Specialty Pharmacy Continuum