Research & Development
Pfizer's supplemental new drug application for Xeljanz receives positive FDA committee response
12 March 2018 -

The US Food and Drug Administration's (FDA) Gastrointestinal Drugs Advisory Committee has granted positive response to United States-based Pfizer for its supplemental new drug application on Xeljanz (tofacitinib), it was reported on Friday.

The product is intended to treat adult patients with moderately to severely active ulcerative colitis. It is a Janus kinase inhibitor, which is yet to secure approval for the treatment of ulcerative colitis.

The US FDA and the European Medicines Agency (EMA) are presently reviewing the applications for the product to treat moderately to severely active ulcerative colitis. The 15-member US FDA committee has voted unanimously in favour of the extension of the use of tofacitinib 10mg twice-daily from 8 to 16 weeks of induction in adult patients who have not achieved adequate therapeutic benefit by week eight.

Xeljanz or Xeljanz XR is already approved in certain circumstnces for the treatment of adult patients with active psoriatic arthritis.

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