New FDA Approvals: FDA Approves Tremfya for UC

  • 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
    © 2024 MMIT
  • Angela Maas

    Angela has an extensive background of editing, reporting and writing for trade and consumer publications. She has written Radar on Specialty Pharmacy since she joined AIS Health in 2005 and has broad knowledge of the various issues at play within the space. She also has written for Spotlight on Market Access since its 2017 launch. Before joining AIS Health, she was managing editor at Employee Benefit News and Employee Benefit News Canada and managing editor at Hem Aware (a hemophilia publication), Lupus Living and Momentum (a multiple sclerosis publication). She has a B.A. in English and an M.A. in British literature from Arizona State University.

The Latest
Meet Our Reporters

Meet Our Reporters

×
×