Scrip 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

AbbVie’s Rinvoq Delay By US FDA Could Foreshadow More Trouble For JAKs

With JAK inhibitors Under A Cloud Of Scrutiny Over Safety, FDA Seeks More Benefit-Risk Data

Executive Summary

The expansion of upadacitinib for a new indication in psoriatic arthritis has been pushed out three months to late in the second quarter.

You may also be interested in...



FDA Warnings And Restrictions On JAKs Curb Growth Potential Of Big Brands

Pfizer, AbbVie and Lilly will face new safety restrictions on Xeljanz, Rinvoq and Olumiant. Indication expansion remains uncertain, while first-line use appears out of the question.

Rinvoq Shows Strong UC Efficacy, But Will JAK Ghosts Haunt It?

Safety appears balanced between the drug and placebo arms in upadacitinib’s third Phase III trial in ulcerative colitis, but there were low numbers of MACE and there are lingering safety concerns about the JAK class overall.

What Will JAK Inhibitor Safety Jitters Mean For Drug Sales?

Together with a similar delay for AbbVie’s Rinvoq, the delays appear to stem from a study that raised concerns about the class. But the potential sales impact is less clear.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

SC144017

Ask The Analyst

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

Thank you for submitting your question. We will respond to you within 2 business days. 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