EU Approves Subcutaneous Tocilizumab for Rheumatoid Arthritis


Systemic JIAThe EU approved the formidable drug Tocilizumab, also known as the brand name RoACTEMRA, which is marketed by Roche Pharmaceuticals, at the end of April 2014. As the only FDA approved medication for treating systemic JIA and polyarticular JIA in children, Tocilizumab is well regarded in the United States. Tocilizumab is approved by both the FDA and now the EU for the treatment of moderate to severe rheumatoid arthritis in adults, with or without the concomitant use of Methotrexate. Currently the most common administration of Tocilizumab is executed via an intravenous infusion, which is typically dispensed once every four weeks. Given in a hospital setting the I.V. treatment of Tocilizumab usually takes one hour to administer, and rarely causes adverse effects. Minor side effects include headache, runny nose and sneezing. However, the recent approval of Tocilizumab in the EU is unique as the method of delivery is a subcutaneous injection, which patients can have administered in their physician’s office or choose to self-inject. Both the I.V and subcutaneous forms of Tocilizumab have been approved and available in the United States and Japan since 2013.

RoACTEMRAThe novel self-injectable form of Tocilizumab achieved EU approval at the end of April 2014 to specifically treat adult patients with moderate or severe Rheumatoid arthritis (RA) who have failed to respond to other medications or who are intolerant to prior treatments. RoACTEMRA is the first and only anti IL-6 receptor biologic that is offered as both an intravenous treatment and a subcutaneous injection to be used alone or in combination with Methotrexate. The option for patients to self-inject creates a personalized opportunity for users of Tocilizumab to decide how and when they want to receive their monthly treatments. The option of a self-injectable form of treatment will offer patients a greater convenience which will hopefully promote better medication adherence.

The approval form the EU of the self-injectable form of Tocilizumab was based on two successful Phase 3 trials coined BREVACTA and SUMMACTA. Both trials demonstrated that the subcutaneous for of Tocilizumab was absolutely comparable to the intravenous form of Tocilizumab, in efficacy, safety and tolerability. Additional encouraging information was gleaned from these studies as well, as patients who received the subcutaneous injections of Tocilizumab showed a reduced progression of joint damage and demonstrated long term efficacy over a 48 week period, as compared to a placebo.

LGM Pharma supplies the API Tocilizumab CAS# 375823-41-9 for research and development purposes. Clients can be assured of quality API products and continuous support throughout the R&D process.

 

Products currently covered by valid US Patents are offered for R&D use in accordance with 35 USC 271(e)+A13(1). Any patent infringement and resulting liability is solely at buyer risk.

  • Share: