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

EU Confirms Sirukumab Filing Withdrawal, J&J Moves On

Executive Summary

Janssen-Cilag has withdrawn the EU marketing application for the IL-6 inhibitor sirukumab, with the CHMP saying the long-term safety of sirukumab had not been well characterized and further clinical studies were required, a conclusion also drawn earlier by the US FDA.

You may also be interested in...



J&J Prepares For US Sirukumab Launch After Regaining Rights From GSK

GSK returned US rights to the IL-6 blocker to J&J as it prioritizes its pharma portfolio under the leadership of new CEO Walmsley.

Sanofi/Regeneron's Kevzara Priced To Break Into A Crowded Market

The partners are looking to create a compelling value proposition for the interleukin-6 inhibitor, approved by FDA to treat moderate to severe RA, by pricing it below the market-leading anti-TNFs.

Pipeline Watch: Phase III Readouts in Wilson Disease, Parkinson's Disease And COVID-19

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

Topics

Related Companies

UsernamePublicRestriction

Register

SC099858

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