Drug Discovery and Development

  • Home Drug Discovery and Development
  • Drug Discovery
  • Women in Pharma and Biotech
  • Oncology
  • Neurological Disease
  • Infectious Disease
  • Resources
    • Video features
    • Podcast
    • Voices
    • Views
    • Webinars
  • Pharma 50
    • 2025 Pharma 50
    • 2024 Pharma 50
    • 2023 Pharma 50
    • 2022 Pharma 50
    • 2021 Pharma 50
  • Advertise
  • SUBSCRIBE

GSK Announces EU Regulatory Submission for Sirukumab in RA

By Drug Discovery Trends Editor | September 14, 2016

GlaxoSmithKline announced the regulatory submission of a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) seeking approval of subcutaneous formulation of sirukumab, a human anti-interleukin (IL)-6 monoclonal antibody, for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA). The MAA seeks approval for sirukumab in combination with methotrexate in RA patients who have failed or are intolerant to conventional or biologic disease-modifying antirheumatic drugs (DMARDs) and as a monotherapy in these patients for whom treatment with methotrexate is inappropriate.

Sirukumab is being co-developed for RA as part of a collaboration with Janssen Biologics (Ireland) [Janssen].

Paul-Peter Tak, GSK’s Chief Immunology Officer & Senior Vice President R&D Pipeline, said: “We have worked with our partner Janssen to develop a robust regulatory package to support the use of sirukumab in adult patients who, despite the use of conventional and biologic therapies, still suffer from moderately to severely active rheumatoid arthritis. We believe sirukumab, if approved, will provide these patients with a once every four week subcutaneous treatment option.”

Sirukumab is an investigational human monoclonal IgG1 kappa antibody that selectively binds with high affinity to the IL-6 cytokine, a naturally occurring protein that plays a role in autoimmune conditions. It is one of the ~40 assets profiled to investors at GSK’s R&D event in November 2015 and belongs to the company’s immuno-inflammation portfolio – one of six core areas of scientific research and development alongside oncology, vaccines and infectious, respiratory and rare diseases.

Approval is being sought for the subcutaneous formulation of sirukumab in two presentations, a single-dose prefilled syringe and a single-dose autoinjector. The data to support the file are based on a comprehensive phase III clinical development programme involving more than 3,000 patients.

A regulatory submission to the United States Food and Drug Administration is also planned for 2016. Sirukumab is currently not approved as a treatment for any indication anywhere in the world.


Filed Under: Drug Discovery

 

Related Articles Read More >

Swissmedic approves first malaria treatment for infants
Korean team reports all-in-one cancer nanomedicine in pre-clinical studies
Nektar’s Phase 2b atopic dermatitis win triggers 1,746% analyst target surge, but legal tussle with ex-partner Lilly could complicate path forward
Dupixent approved to treat bullous pemphigoid
“ddd
EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
Get the latest news and trends happening now in the drug discovery and development industry.

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.
Drug Discovery and Development
  • MassDevice
  • DeviceTalks
  • Medtech100 Index
  • Medical Design Sourcing
  • Medical Design & Outsourcing
  • Medical Tubing + Extrusion
  • Subscribe to our E-Newsletter
  • Contact Us
  • About Us
  • R&D World
  • Drug Delivery Business News
  • Pharmaceutical Processing World

Copyright © 2025 WTWH Media LLC. All Rights Reserved. The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media
Privacy Policy | Advertising | About Us

Search Drug Discovery & Development

  • Home Drug Discovery and Development
  • Drug Discovery
  • Women in Pharma and Biotech
  • Oncology
  • Neurological Disease
  • Infectious Disease
  • Resources
    • Video features
    • Podcast
    • Voices
    • Views
    • Webinars
  • Pharma 50
    • 2025 Pharma 50
    • 2024 Pharma 50
    • 2023 Pharma 50
    • 2022 Pharma 50
    • 2021 Pharma 50
  • Advertise
  • SUBSCRIBE