FDA approves Mirikizumab for ulcerative colitis

By admin

Mirikizumab- a monoclonal antibody, recently received FDA approval to treat moderate to severely active ulcerative colitis in adults. The efficacy and safety were evaluated in two randomized, double-blind, placebo-controlled trials. The major benefits of the drug include reduced rectal bleeding, reduced stool frequency and bowel urgency.

Mechanism of action:

Mirikizumab is a humanized IgG4 monoclonal antibody that blocks the action of IL-23 (a proinflammatory cytokine).
Throughout the trial, the drug consistently reduced the severity of the disease. It also improved response to anti TNF treatment, demonstrating the beneficial effects of IL-
23 inhibition.

Dosage and administration:

  • Induction dose: 300 mg administered as an intravenous infusion over 30 minutes, at weeks 0, 4 and 8.
  • Maintenance dose: 200 mg administered as a subcutaneous injection (2consecutive injections of 100 mg each), given at week 12 and every 4 weeks thereafter.


  • Hypersensitivity reactions (anaphylaxis during infusion, mucocutaneous erythema, pruritus during induction)
  • Increased risk of infection
  • Hepatotoxicity
  • Live vaccines

Adverse reactions:

  • Upper respiratory tract infections
  • Arthralgia, rash
  • Headache
  • Herpes viral infection, worsening of active TB infection
  • Hypersensitivity reactions.




Spread the love


Leave a Comment