Pharmaceutical Processing World

  • Home
  • Regulatory
    • Recalls
  • Pharmaceutical Processing
  • Facility
  • Supply Chain
  • Equipment and Materials
  • Contract Manufacturing
  • Advertise
  • SUBSCRIBE

Roche Submits sBLA to FDA for ACTEMRA

By Pharmaceutical Processing | March 17, 2010

Roche has submitted a supplemental Biologics License Application (sBLA) to the FDA for ACTEMRA (tocilizumab, RoACTEMRA in the European Union) for the prevention of structural joint damage and to improve physical function in adults with moderately to severe active rheumatoid arthritis (RA). 

ACTEMRA was approved by the FDA on January 8, 2010 as the first interleukin-6 (IL-6) receptor-inhibiting monoclonal antibody to treat RA in adult patients after an inadequate response to at least one other medicine called a tumor necrosis factor (TNF) antagonist. RoACTEMRA was approved in the European Union in January 2009 for the treatment of RA in patients who have either responded inadequately to, or who were intolerant to, previous therapy with one or more DMARDs or TNF inhibitors. In September 2009 Roche submitted a filing to the European health authorities (the European Medicines Agency) to extend the indication of RoACTEMRA to inhibit the progression of joint damage and to improve physical function in patients with RA.

The US FDA application is based on positive results from the phase III LITHE1 trial which showed that patients receiving ACTEMRA in combination with methotrexate (MTX) had significantly less damage to their joints at two years, compared to patients who received MTX alone.  The outcome was determined by x-rays which measured over time the progression of bone erosions and narrowing of joint spaces. The data showed that with long-term use, patients with rheumatoid arthritis treated with ACTEMRA 8mg/kg plus MTX suffered 81% less damage to their joints compared to those treated in the control group at Week 104.

The LITHE study also showed that patients who received either dose of ACTEMRA plus methotrexate showed significant improvement in physical function, compared with patients who received methotrexate plus placebo at Weeks 52 and 104, as measured by the mean area under the curve (AUC) of the Health Assessment Questionnaire Disability Index (HAQ-DI)i change from baseline.

“These data suggest that in addition to reducing the painful signs and symptoms of RA, ACTEMRA inhibits the progression of the disease by reducing long-term joint damage and improves physical function which are important goals of treating this chronic, debilitating disease,” said Hal Barron, M.D., executive vice president, Global Development and chief medical officer.

 

 

Related Articles Read More >

Doctor, woman patient and tablet for consulting with results, medical info and talk for healthcare with mockup space. Japanese medic, digital touchscreen or show video for surgery, wellness or advice.
Putting patients first in clinical trials
Confidently navigate the transition from bench to batch
Merck
FDA approves Merck’s Winrevair to treat pulmonary arterial hypertension
kobayashi pharmaceutical logo
Report: Japan health authorities investigate Kobayashi Pharmaceutical factory after five deaths
“ppw
EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
Get the latest news, technologies, and developments in Pharmaceutical Processing.

DeviceTalks Tuesdays

DeviceTalks Tuesdays

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.
Pharmaceutical Processing World
  • Subscribe to our E-Newsletter
  • Contact Us
  • About Us
  • R&D World
  • Drug Delivery Business News
  • Drug Discovery & Development
  • DeviceTalks
  • MassDevice
  • Medical Design & Outsourcing
  • MEDICAL TUBING + EXTRUSION
  • Medical Design Sourcing
  • Medtech100 Index
  • R&D 100 Awards

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 Pharmaceutical Processing World

  • Home
  • Regulatory
    • Recalls
  • Pharmaceutical Processing
  • Facility
  • Supply Chain
  • Equipment and Materials
  • Contract Manufacturing
  • Advertise
  • SUBSCRIBE