FDA Approves Golimumab for Ulcerative Colitis

May 16, 2013

The FDA has approved the tumor necrosis factor (TNF) blocker golimumab (Simponi) for treatment of moderate to severe ulcerative colitis in adults. This is the first non-arthritis indication for the biologic, which is already approved for rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis.

The FDA has approved the tumor necrosis factor (TNF) blocker golimumab (Simponi) for treatment of moderate to severe ulcerative colitis in adults. This is the first non-arthritis indication for the biologic, which is already approved for rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis.

The drug is specifically approved for ulcerative colitis (UC) refractory to other treatments or requiring chronic steroid therapy.

The approval is based on

, the first a 513-patient randomized trial showing that the drug achieved improved clinical response, endoscopy-documented improvement in inflammation, and greater likelihood of remission compared to placebo. A second randomized placebo-controlled trial showed a significantly greater likelihood of remission sustained through week 54 among UC patients treated with the biologic agent than among those on placebo. 

To treat UC, a 200 mg subcutaneous injection of golimumab should be administered at week zero, followed by 100 mg at week two and then 100 mg every four weeks thereafter.