Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

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’s Xeljanz Could See Narrower Label And New REMS Due To CV And Malignancy Risks

Executive Summary

The US FDA will ponder its regulatory options now that final data are in from a long-term postmarketing study showing tofacitinib is associated with a higher rate of major adverse cardiovascular events and malignancies compared with TNF-inhibitors.

You may also be interested in...



US FDA Restricts JAK Inhibitors To Second-Line In Rheumatoid Arthritis Amid CV, Cancer, Mortality Risks

Now that the analysis of Pfizer’s postmarketing trial for Xeljanz is complete, though, application reviews of other products will likely be completed. The Xelijanz study revealed elevated risk of heart-related events, cancer, blood clots and death, resulting in a class-wide indication restriction and a revised boxed warning.

AbbVie’s Q1 Revenue Growth Outpaces Big Pharma Peers

Bouncing back from the pandemic more strongly than its peers, AbbVie sees 40% growth for Botox and Juvederm, a good launch for Ubrelvy and continued strength from its mainstays.

Patient-Focused Meeting On Vitiligo Could Galvanize R&D As The First Drug Candidates In A Long Time Advance

US FDA meeting directs attention to the vitiligo patient experience as a small group of potential treatments, led by topical Janus kinase inhibitors, are at the Phase II hinge point.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

PS143764

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