NulojixTreatment for Organ Transplant -- Rejection Prophylaxis
Update: Nulojix (belatacept) Now FDA Approved - June 15, 2011
Complete Response Letter for Belatacept
Bristol-Myers Squibb Receives Complete Response Letter from FDA for Belatacept
PRINCETON, N.J.--(BUSINESS WIRE)--May 1, 2010 - Bristol-Myers Squibb Company today announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter regarding the Biologics License Application for belatacept in kidney transplantation.
While no new clinical studies have been requested, the complete response letter requests the 36-month data from the ongoing Phase 3 studies to further evaluate the long-term effect of belatacept. The company will work with the FDA to provide the data as soon as they are available. The Biologics License Application submitted for belatacept included 24-month data from the Phase 3 studies.
Other requests raised in the letter primarily relate to information to support the manufacturing of belatacept and the proposed risk evaluation and mitigation strategy (REMS).
"Bristol-Myers Squibb is committed to belatacept as a potential new therapeutic option for kidney transplant patients," said Brian Daniels, senior vice president, Global Development and Medical Affairs, Bristol-Myers Squibb. "We will continue to work closely with the FDA to address their questions."
The Biologics License Application for belatacept was accepted for filing and review by the FDA in September 2009. An FDA Advisory Committee panel met on March 1 of this year and voted 13-5 to recommend the approval of belatacept for the prophylaxis of rejection in kidney transplant recipients. The FDA is not bound by the recommendations of its Advisory Committee, but takes its advice into consideration when reviewing new drug applications.
Belatacept is an investigational agent under development by Bristol-Myers Squibb for the prophylaxis of organ rejection in adult patients receiving kidney transplants.
Belatacept is a fusion protein designed to be a selective T cell 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 T cells, which are the predominate immune mediators of allograft rejection.
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 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 belatacept will receive regulatory approval or, if approved, that it 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.
Posted: May 2010
- FDA Approves Nulojix for Kidney Transplant Patients - June 16, 2011
- FDA Advisory Committee Recommends Approval of Belatacept, an Investigational Agent for Prophylaxis of Acute Rejection in De Novo Kidney Transplant Patients - March 2, 2010
- Bristol-Myers Squibb Announces Acceptance of Submission for Belatacept Biologic License Application - September 3, 2009