EU Food and Drug Administration recommends golimumab for ulcerative colitis

EU Food and Drug Administration recommends golimumab for ulcerative colitis The European Union (EU) Food and Drug Administration recommends the approval of Golimumab (Simponi, Janssen Bio) for the treatment of adult patients with moderate-severe ulcerative colitis (UC) who are ineffective or unable to receive conventional treatment.

Traditional treatments for ulcerative colitis include corticosteroids and 6-mercaptopurine or azathioprine.

Golimumab, a monoclonal antibody, inhibits tumor necrosis factor, a causative cytokine of inflammatory diseases.

Following the approval of Golimumab for ulcerative colitis on May 15 by the US Food and Drug Administration, the European Medicines Agency (EMA) Human Drug Management Committee made the same recommendations. Like the United States, the European Union also recommends the use of the drug in three situations: moderate to severe rheumatoid arthritis (in combination with methotrexate), psoriatic arthritis, and ankylosing spondylitis.

The European Commission, the executive arm of the European Union, is expected to approve the EMA's recommendations in the coming months.

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