Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Centocor and Schering-Plough have announced that a marketing authorization application has been submitted to the European Medicines Agency requesting the approval of golimumab as a monthly subcutaneous treatment for adults with rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis.
Subscribe to our email newsletter
Golimumab, Centocor’s and Schering-Plough’s next-generation human anti-TNF-alpha monoclonal antibody, is being studied as an every four week subcutaneous injection and an intravenous (IV) infusion therapy. Pending regulatory approval in the EU, Schering-Plough Corporation will assume exclusive marketing rights for golimumab in Europe.
The initial submission and Phase III development programs are unprecedented among anti-tumor necrosis factor (TNF)- alpha therapies, as they mark the first time that an marketing authorization application (MAA) has been proposed for review inclusive of three unique disease states.
Jerome Boscia, senior vice president, clinical research and development, Centocor, said: “We remain focused and on track for global regulatory submissions for golimumab targeted for the first half of 2008.”