Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

Pfizer Xeljanz's Long-term Dosing Raises Safety Concerns In Ulcerative Colitis

Executive Summary

US FDA's Gastrointestinal Drugs Advisory Committee will weigh proposed indication as agency appears uncertain whether higher dose can be used as long-term therapy.

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 Xeljanz: Duration Of 10 mg Dose In Ulcerative Colitis Could Hinge On Post-Market Commitment

Postmarket trial looking at reduced doses in UC may be difficult to enroll, Pfizer argues; with approval of expanded indication seeming assured, another postmarket question for Xeljanz could look at impact of herpes zoster vaccine.

Xeljanz's UC Indication On Track With Higher Doses After Unanimous Advisory Committee Votes

US FDA's Gastrointestinal Drugs Advisory Committee says higher dosing regimens can be used despite agency worries about safety with long-term use.

Related Content

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

PS122649

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel