Last Updated: 2010-03-01 19:30:15 -0400 (Reuters Health)
WASHINGTON, March 1 (Reuters) - Bristol-Myers Squibb Co's experimental kidney transplant drug belatacept should be approved to give doctors and patients more treatment choices, but long-term data and a stringent patient registry are needed, U.S. medical advisers said on Monday.
The U.S. Food and Drug Administration advisory panel, in a 13-5 vote, said the company's overall data supported use of the drug to prevent acute kidney rejection in transplant patients and that most of the data could be collected after the drug is in use, if it wins ultimate agency approval.
Panel chairman Dr. Emil Paganini, an Ohio-based physician who backed approval, said it was the unknown safety issues that worried him, calling for "a rather tight" patient registry as well as at least three years of data following up patients.
Bristol-Myers is seeking FDA approval of the injectable biologic drug to prevent organ rejection and maintain kidney function in patients with end-stage renal disease, saying it offers benefits over current therapies.
(In a phase III trial reported this month in the American Journal of Transplantation, belatacept-based immunosuppression after kidney transplantation allowed for better renal function compared to cyclosporine, with similar graft and patient survival. See Reuters Health report dated February 24, 2010.)
Agency officials will consider the panel's recommendation before making the final approval decision, expected by May 1.
Most panelists noted that belatacept was not quite as effective as cyclosporine. That trade off, though was worth it, said panelist Dr. Frederick Kaskel, because "We need to offer patients options."
FDA staff reviewers have cited concerns about possible serious complications even though data showed better heart risks and kidney function, citing several cases of progressive multifocal leukoencephalopathy.
Several panel members urged the FDA to take a more cautious approach.
Dr. Darren McGuire, a medical professor at the University of Texas Southwestern Medical Center in Dallas, said he was not convinced the company's data showed the drug worked well enough and that more study was needed before approval, not after.
"I think it's promising, but ... we have no data about the longer term outcomes," said Dr. McGuire, who voted against approval.
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