Centocor, Inc. announced today 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.
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