Xeljanz's UC Indication On Track With Higher Doses After Unanimous Advisory Committee Votes
Executive Summary
US FDA's Gastrointestinal Drugs Advisory Committee says higher dosing regimens can be used despite agency worries about safety with long-term use.
You may also be interested in...
Pfizer's Xeljanz Approval In UC Includes Postmarket Study On Long-Term Effects
JAK inhibitor, now first oral UC medication in US, is approved for both 5mg and 10mg, but label currently discourages 10mg after 16 weeks.
Pfizer's Xeljanz Pushed By New Tailwind From Approval In Ulcerative Colitis
FDA approved the JAK inhibitor as the first oral medicine for moderate to severe ulcerative colitis, providing Pfizer with fertile new commercial ground for the blockbuster drug.
Arena Ready For Etrasimod Phase III Face-Off With Celgene's Ozanimod In UC
With significant Phase II results in ulcerative colitis, Arena is planning a Phase III program for its selective S1P receptor modulator etrasimod – a drug that it thinks can best Celgene's S1P-targeting therapy ozanimod on safety and possibly efficacy.