New FDA Approvals: FDA Approves Tremfya for UC
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Oct 10, 2024
Sept. 11: The FDA granted another indication to Johnson & Johnson Innovative Medicines’ Tremfya (guselkumab) for the treatment of adults with moderately to severely active ulcerative colitis. The agency initially approved the interleukin-23 (IL-23) antagonist on July 13, 2017. It is the third IL-23 inhibitor approved for the condition, following AbbVie Inc.’s Skyrizi (risankizumab-rzaa) and Lilly’s Omvoh (mirikizumab-mrkz). Dosing for the new indication starts at 200 mg via intravenous infusion over at least one hour at weeks zero, four and eight, and then maintenance dosing is 100 mg via subcutaneous injection at week 16 and every eight weeks thereafter or 200 mg at week 12 and every four weeks thereafter. Drugs.com lists the price of 100 mg/mL as more than $14,617. Read more
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