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


Janssen's Sirukumab Brings Mortality Imbalance Into FDA Panel Review

Executive Summary

Unfavorable trends in all-cause death, malignancy and major adverse cardiovascular events are key safety issues facing US agency's Arthritis Advisory Committee, which also is being asked to weigh adequacy of Janssen's dose selection and, more generally, use of long-term placebo controls in rheumatoid arthritis studies.

You may also be interested in...

Ethics Of Kevzara's 52-Week Placebo Trial Weighed On US FDA

Although lengthy duration of placebo treatment was not flagged for concern in first-cycle review of Sanofi/Regeneron's sarilumab for rheumatoid arthritis, it drew considerable attention in the BLA's second go-around at FDA, which included an ethics consult and a center director briefing.

Janssen's Sirukumab Falls On Mortality Concerns At US FDA Panel

But advisory committee members suggest narrower indication might have won their support. In recommending against approval for rheumatoid arthritis, panelist were uncertain whether imbalance in deaths in the placebo-controlled trials resulted from an artifact of trial design or a real safety signal.

Too Little, Too Late For GSK/Janssen's Sirukumab in RA?

Full data for the Phase III SIRROUND-D study of GlaxoSmithKline PLC/Janssen Pharmaceuticals Inc.'s sirukumab show early and good separation over placebo in rheumatoid arthritis, but the third-placed anti-IL6 product will have to work hard to catch up with its more advanced rivals, Actemra (tocilizumab) and sarilumab.


Related Companies




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