FDA panel backs Bristol transplant drug

WASHINGTON Mon Mar 1, 2010 6:39pm EST

Related Topics

WASHINGTON (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 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 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.

Agency officials will consider the panel's recommendation before making the final approval decision, expected by May 1.

Patients with chronic renal disease who undergo kidney transplantation face the potential that their body will reject their new organ and must take preventative drugs.

Representatives for Bristol told the FDA's advisers that belatacept offered greater overall benefit as well as avoids the toxicities seen with another rejection drug known as cyclosporine.

Most panelists noted that belatacept was not quite as effective as current treatments such as cyclosporine, a type of calcineurin inhibitor (CNIs) sold as Abbott Laboratories' Gengraf and Novartis's Sandimmune and Neoral.

That trade off, though was worth it, said panelist 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 post-transplantation complication and a rare disorder called progressive multifocal leukoencephalopathy (PML).

Several panel members urged the FDA to take a more cautious approach.

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 McGuire, who voted against approval.

Bristol welcomed the panel vote in a statement after the meeting. Before the panel's vote, shares of Bristol earlier closed off 0.5 percent at $24.39 on the New York Stock Exchange.

(Reporting by Susan Heavey; Editing by Richard Chang and Carol Bishopric)

FILED UNDER: