BioCentury
ARTICLE | Clinical News

Nulojix belatacept regulatory update

June 27, 2011 7:00 AM UTC

The European Commission approved an MAA from Bristol-Myers Squibb 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. ...