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  • Prescription guidance and label change for Xeljanz on UC
  • by Nho, Byung Chul | translator Byun Kyung A | Feb 25, 2020 06:11am
MFDS in process of revising indication for Xeljanz, finalized by next month at earliest
FDA and EMA push down treatment line and recommends reserving the drug to high risk patient
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The Korean health authority is predicted to narrow down the use of Pfizer¡¯s treatment for patients with ulcerative colitis, Xeljanz (tofacitinib citrate) soon.

Ministry of Food and Drug Safety (MFDS) is expected to conclude its decision on pharmaceutical safety and revising related indication of Xeljanz, as discussed in-depth with Pfizer Korea over last year.

MFDS could not disclose details of the revised indication, but the ministry would highly likely to follow decisions by the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA).

In last July, the U.S. FDA has pushed down the treatment line of Xeljanz from first-line treatment for ulcerative colitis to second-line treatment.

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