NulojixTreatment for Organ Transplant -- Rejection Prophylaxis
Update: Nulojix (belatacept) Now FDA Approved - June 15, 2011
FDA Accepts Belatacept BLA Submission
Bristol-Myers Squibb Announces Acceptance of Submission for Belatacept Biologic License Application
NEW YORK--(BUSINESS WIRE)--Sep 3, 2009 - Bristol-Myers Squibb Company announced today that the U.S. Food and Drug Administration (FDA) has accepted, for filing and review, the company's submission of a biologic license application for belatacept, which is in ongoing phase III development for use in kidney transplantation.
The Prescription Drug User Fee Act (PDUFA) goal date for the FDA is May 1, 2010.
"Belatacept has the potential to address significant unmet medical needs of transplant patients," said Elliott Sigal, M.D., Ph.D., executive vice president, chief scientific officer and president, Research and Development, Bristol-Myers Squibb. "We are pleased the FDA has accepted our submission and we look forward to continuing to work with the agency."
Belatacept is an investigational agent under development by Bristol-Myers Squibb to help prevent graft rejection and maintain kidney function following renal transplantation. Belatacept is being studied to assess its efficacy and safety as a maintenance immunosuppressant agent.
Belatacept is a fusion protein designed to be a selective co-stimulation blocker that binds to a specific site on certain cells of the immune system (i.e., antigen presenting cells) to block the second signal necessary to activate naïve T-cells, which coordinate immune-mediated rejection of transplanted organs.
About Bristol-Myers Squibb
Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to extend and enhance human life. For more information, visit: www.bms.com.
Bristol-Myers Squibb Forward-Looking Statement
This press release contains "forward-looking statements" relating to the development and commercialization of products. 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 the product described in this release will receive regulatory approval. There can be no assurance that, if approved, the product will be commercially successful. Forward-looking statements in the 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, 2008, its Quarterly Reports on Form 10-Q, and 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.
Posted: September 2009
- FDA Approves Nulojix for Kidney Transplant Patients - June 16, 2011
- Bristol-Myers Squibb Receives Complete Response Letter from FDA for Belatacept - May 3, 2010
- FDA Advisory Committee Recommends Approval of Belatacept, an Investigational Agent for Prophylaxis of Acute Rejection in De Novo Kidney Transplant Patients - March 2, 2010