Zymfentra FDA Approval History
Last updated by Judith Stewart, BPharm on Oct 31, 2023.
FDA Approved: Yes (First approved October 20, 2023)
Brand name: Zymfentra
Generic name: infliximab-dyyb
Dosage form: Subcutaneous Injection
Company: Celltrion USA
Treatment for: Crohn's Disease, Ulcerative Colitis
Zymfentra (infliximab-dyyb) is a tumor necrosis factor (TNF) blocker used for the maintenance treatment of ulcerative colitis and Crohn’s disease in adults.
- Ulcerative colitis and Crohn’s disease are disorders characterized by chronic inflammation of the gastrointestinal (GI) tract.
- Zymfentra works in the treatment of ulcerative colitis and Crohn’s disease by blocking the action of tumor necrosis factor-alpha (TNF-alpha), a protein that can be overproduced in response to certain diseases and cause the immune system to attack normal, healthy parts of the body.
- Zymfentra contains infliximab-dyyb, and is a subcutaneous injection formulation of Celltrion’s infliximab biosimilar Inflectra. Inflectra (infliximab-dyyb) was the first FDA approved biosimilar to Remicade (infliximab). Inflectra and Remicade are intravenous injection formulations of infliximab indicated for the treatment of ulcerative colitis and Crohn’s disease in adults, and also pediatric ulcerative colitis, pediatric Crohn’s disease, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, and plaque psoriasis.
- FDA approval of Zymfentra was based on the results of the LIBERTY UC and LIBERTY CD studies, which demonstrated superiority in the primary endpoints of clinical remission (UC and CD) and endoscopic response (CD) compared to placebo as maintenance therapy after induction therapy of intravenous formulation of infliximab in patients with UC and CD, over a 54-week study period.
- Zymfentra is administered by subcutaneous injection following induction therapy with an intravenous formulation of infliximab.
- Warnings and precautions associated with Zymfentra include serious infections (including invasive fungal infections), increased risk of malignancies, hepatitis B virus (HBV) reactivation, hepatotoxicity, congestive heart failure, hematologic abnormalities, hypersensitivity reactions, neurologic reactions, increased risk of infection with concurrent administration of other biological products, risk of additive immunosuppressive effects from prior biological products, and formation of autoantibodies and development of lupus-like syndrome. It is recommended patients are up to date with all vaccinations prior to starting treatment. Live vaccines or therapeutic infectious agents should not be given with Zymfentra.
- Common adverse reactions in ulcerative colitis patients include COVID-19, anemia, arthralgia, injection site reaction, increased alanine aminotransferase, and abdominal pain.
Common adverse reactions in Crohn’s Disease patients include 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.
Development timeline for Zymfentra
| Date | Article |
|---|---|
| Oct 23, 2023 | Approval FDA Approves Zymfentra (infliximab-dyyb) Subcutaneous Formulation for the Treatment of People With Inflammatory Bowel Disease |
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
