Guest guest Posted June 30, 2008 Report Share Posted June 30, 2008 Centocor, Inc. Submits Application To FDA Requesting Approval Of Golimumab For The Treatment Of Rheumatoid Arthritis MedicalNewsToday.com Article Date: 28 Jun 2008 - 0:00 PDT -------------------------------------------------------------------------------- Centocor, Inc. announced that a Biologics License Application (BLA) has been submitted to the U.S. Food and Drug Administration (FDA) requesting the approval of golimumab (CNTO 148) as a monthly subcutaneous treatment for adults with active forms of rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis. Golimumab, Centocor's next-generation human anti-TNF-alpha monoclonal antibody, is being studied as an every four week subcutaneous injection and is also being studied as an intravenous (IV) infusion therapy. In February 2008, Centocor submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMEA) requesting the approval of golimumab as a monthly subcutaneous treatment for the same indications. ************************************************ Read the entire article here: http://www.medicalnewstoday.com/articles/113167.php -- Not an MD Quote Link to comment Share on other sites More sharing options...
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