Centocor and Schering-Plough submit MAA for arthritis drug

Mar 19, 2008 (Datamonitor via COMTEX) -- SGP | news | PowerRating | PR Charts -- 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.

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."

http://www.datamonitor.com

Republication or redistribution, including by framing or similar means, is expressly prohibited without prior written consent. Datamonitor shall not be liable for errors or delays in the content, or for any actions taken in reliance thereon

More News:   Market Updates | Stock Alerts | All Trading News | Stock Index