Xeljanz recommended for FDA approval

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arronUC
New Member


Date Joined Jun 2017
Total Posts : 13
   Posted 3/8/2018 6:01 PM (GMT -6)   
The FDA's Gastrointestinal Drugs Advisory Committee voted 15 - 0 in favor of including a higher dosing regimen (10 mg twice daily) for Pfizer's (PFE +1.5%) XELJANZ (tofacitinib) for adult patients with moderately to severely active ulcerative colitis (UC) who have not responded adequately to corticosteroids, azathioprine, 6-mercaptopurine or tumor necrosis factor inhibitor therapy. Physicians will have the option of administering 5 mg or 10 mg twice daily for these patients.

The vote was split on the question of the need for a post-marketing efficacy study, 7 in favor and 8 opposed.

The FDA's action date is in June.

https://seekingalpha.com/news/3337726-fda-ad-com-back-pfizers-xeljanz-certain-uc-patients-shares-2-percent

iPoop
Forum Moderator


Date Joined Aug 2012
Total Posts : 13246
   Posted 3/8/2018 6:59 PM (GMT -6)   
Awesome, easier for us to get when it's officially approved for uc (rather than off-label).
Moderator Ulcerative Colitis
John
, 39, UC Proctosigmoiditis
Rx: Remicade @5mgs/kg/6wks; daily 75mgs 6MP, 4.8g generic-Lialda, and rowasa

UC experience: wakeup with noisy bowels so no lingering in bed, soon after poop with discomfort/pain/mild-nausea, eat something, poop, get dressed, poop, leave in car and worry whole drive about more...
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