Bristol-Myers
Squibb Company (NYSE:BMY) 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”
“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.
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