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  • Ulcerative colitis added to Stelara's domestic indications
  • by Eo, Yun-Ho | translator Choi HeeYoung | Dec 23, 2019 06:29am
Approved last month by the MFDS, its scope of use expanded following psoriasis and Crohn's disease.
Meets endpoints such as clinical remission through phase III UNIFI program
Janssen's interleukin-12/23 (IL-12/23) inhibitor 'Stelara' can be prescribed for ulcerative colitis.
According to the industry, the KFDS recently approved Janssen's Stelara (Ustekinumab) as a treatment for moderate to severe adult active ulcerative colitis.
As a result, Stelara has acquired four indications in Korea, including ulcerative colitis, plaque psoriasis, psoriatic arthritis, and Crohn's disease.

The expansion of Stelara's ulcerative colitis indications was based on the UNIFI program, Phase III. The program consisted of one maintenance therapy with subcutaneous injection every 8 weeks for 44 weeks after one initial induction study with a single intravenous injection of Stelara.

The study found that 19
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