Biotech Values

[DewDiligence]

FDA Issues CRL for BMY’s Belatacept

[This is yet another case where the FDA contravened the vote of the advisory panel, who voted 13-5 in favor of approval (#msg-47249910 ). In three phase-3 trials, Belatacept met the co-primary endpoints by showing superiority relative to cyclosporine on a measurement of renal function and non-inferiority relative to cyclosporine on acute graft rejection, each measured after 12 months of treatment. However, the advisory panel voiced some dissatisfaction with the width of the non-inferiority margin allowed by the FDA on acute graft rejection; had a narrower and more typical NI margin been used, Belatacept would not have met the NI threshold. This and lingering doubts about long-term safety has caused the FDA to ask for the 36-month (final) data from two of the phase-2 trials, which are not yet mature.

BMY considers Belatacept one of its five most consequential new drugs—see the prologue of #msg-47502391.]

http://finance.yahoo.com/news/BristolMyers-Squibb-Receives-bw-1903800508.html?x=0&.v=1

›May 1, 2010, 6:54 pm EDT

PRINCETON, N.J.--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE: BMY) 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.

About Belatacept

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.‹