NulojixTreatment for Organ Transplant -- Rejection Prophylaxis
Update: Nulojix (belatacept) Now FDA Approved - June 15, 2011
FDA Advisory Committee Recommends Approval of Belatacept
FDA Advisory Committee Recommends Approval of Belatacept, an Investigational Agent for Prophylaxis of Acute Rejection in De Novo Kidney Transplant Patients
PRINCETON, N.J.--(BUSINESS WIRE)--Mar 2, 2010 - Bristol-Myers Squibb Company today announced that the U.S. Food and Drug Administration's (FDA) Cardiovascular and Renal Drugs Advisory Committee has voted 13 to 5 to recommend approval of belatacept, a selective co-stimulation blocker, for the prophylaxis of acute rejection in de novo kidney transplant patients. The belatacept Biologics License Application was submitted to the FDA for an indication of prophylaxis of organ rejection and preservation of a functioning allograft in adult patients receiving renal transplants with use in combination with an interleukin-2 (IL-2) receptor antagonist, a mycophenolic acid (MPA), and corticosteroids.
"Bristol-Myers Squibb is encouraged by the Committee's recommendation. We will continue to work closely with the FDA to support the review of belatacept, which has the potential to provide another treatment option for kidney transplant patients," said Brian Daniels, senior vice president, Global Development and Medical Affairs, Bristol-Myers Squibb.
The FDA Cardiovascular and Renal Drugs Advisory Committee based its recommendation on review of data from the belatacept clinical development program, which included more than 1,000 patients who received belatacept. Data presented included safety and efficacy results from three similarly designed clinical studies in adult de novo kidney transplant patients: a Phase 2 study (IM103100) and two Phase 3 studies, one in standard criteria (living or deceased) donor kidney transplants (IM103008) and one in extended criteria donor kidney transplants (IM103027). Belatacept is being studied in other ongoing and planned clinical trials.
The FDA is not bound by the recommendations of its Advisory Committee, but takes its advice into consideration when reviewing new drug applications. The Biologics License Application for belatacept was accepted for filing and review by the FDA in September 2009 and the Prescription Drug User Fee Act goal date for FDA action is May 1, 2010.
Belatacept is an investigational agent under development by Bristol-Myers Squibb to prevent graft rejection and maintain kidney function following renal transplantation. Belatacept is being studied to assess its efficacy and safety as an immunosuppressant agent in solid organ transplantation.
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 committed to discovering, developing and delivering innovative medicines that help patients prevail over serious diseases. For more information, please visit www.bms.com.
Bristol-Myers Squibb Forward-Looking Statement
This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995, regarding the research, development and commercialization of pharmaceutical 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 compound described in this release will receive regulatory approval or, if approved, that it 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, 2009, 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: March 2010
- FDA Approves Nulojix for Kidney Transplant Patients - June 16, 2011
- Bristol-Myers Squibb Receives Complete Response Letter from FDA for Belatacept - May 3, 2010
- Bristol-Myers Squibb Announces Acceptance of Submission for Belatacept Biologic License Application - September 3, 2009