The incidence of all malignancies was stable over time in each study. A Risk Management Plan will be implemented as part of the pharmacovigilance programme to monitor for infections and malignancies.
The most common serious adverse reactions (>= 2%) reported with belatacept cumulative up to Year 3 were urinary tract infection, CMV infection, pyrexia, increased blood creatinine, pyelonephritis, diarrhea, gastroenteritis, graft dysfunction, leukopenia, pneumonia, basal cell carcinoma, anemia and dehydration.
About NULOJIX(R) (belatacept)
NULOJIX is the first approved costimulation blocker for maintenance immunosuppression in kidney transplantation. NULOJIX, a soluble fusion protein, is a selective T-cell costimulation blocker that binds to CD80 and CD86 on antigen-presenting cells. As a result, NULOJIX blocks CD28 mediated costimulation of T cells. In vitro, belatacept inhibits T lymphocyte proliferation and the production of the cytokines interleukin-2, interferon-g, interleukin-4, and TNF-a. Activated T cells are the predominant mediators of immunologic rejection.
About Bristol-Myers Squibb
Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail against serious diseases. Around the world, our medicines are helping millions of patients in their fight against such diseases as cancer, heart disease, HIV/AIDS, psychiatric disorders, rheumatoid arthritis, chronic hepatitis B virus infection and diabetes.
Bristol-Myers Squibb Forward-Looking Statement
This press release contains "forward-looking statements" as the term is defined in the Private Securities Litigation Reform Act of 1995 regarding product development. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. No forward-looking statement can be guaranteed. Among other risks, there can be no guarantee that NULOJIX(R) (belatacept) will become a commercially successful product. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Bristol-Myers Squibb's business, particularly those identified in the cautionary factors discussion in Bristol-Myers Squibb's Annual Report on Form 10-K for the year ended December 31, 2009, in our Quarterly Reports on Form 10-Q and our Current Reports on Form 8-K. Bristol-Myers Squibb undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.
References
1. Hariharan S et al. Kidney Int 2002;62:311-8. 2. Lenihan CR et al. Ren Fail 2008;30:345-52. 3. Salvadori M et al. Transplantation 2006;81(2):202-6. 4. Council of Europe. International Figures on Donation and Transplantation --- 2009: Transplant Newsletter 2010;15:1---76. 5. Belatacept European SmPC. 6. European Medicines Agency. Summary of opinion EMA/CHMP/273603/2011. 14 April 2011.available on http://www.ema.europa.eu/docs/en_GB/docu... ial_authorisation/human/002098/WC500105253.pdf 7. Vincenti F et al. ATC 2011; Abstract 227. 8. Medina Pestana J et al. ATC 2011; Abstract 1088. 9. Ojo AO et al. J Am Soc Nephrol 2001;12:589---97. 10. Larsen C. et al. ATC 2011; Abstract 228.
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