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EC approves Nulojix to prevent organ rejection

June 21, 2011 12:46 AM UTC

The European Commission approved an MAA from Bristol-Myers Squibb Co. (NYSE:BMY) for Nulojix belatacept to prevent organ rejection in adult patients receiving a kidney transplant. Nulojix is indicated for use in combination with mycophenolic acid and corticosteroids and an IL-2 receptor antagonist for induction. Nulojix is approved for use only in patients who are Epstein-Barr Virus (EBV) seropositive. The risk for post-transplant lymphoproliferative disorder (PTLD) is higher in patients who have never been exposed to EBV. ...