HEALTH
Panel Deadlocks
On Drug to Help
With Transplants
By JENNIFER CORBETT DOOREN
DOW JONES NEWSWIRES
June 7, 2005; Page D7
WASHINGTON -- An outside panel of medical experts deadlocked over whether a proposed drug by Chiron Corp. for lung-transplant patients was effective. The panel voted 8 to 8 about whether data presented by the company using a study of just 56 patients was strong enough to show the drug worked.
Several panel members said that while the drug, Pulminiq, showed promise, more study is needed. Chiron said it would conduct an additional five-year study of the drug if it was approved.
"I don't think the yeses and nos are really that far apart," said panel chairman Eric Swenson of the University of Washington, Seattle, the panel's chairman. "We all have great hopes for something like this."
The Food and Drug Administration must decide whether to approve the drug by about the middle of next month. The FDA usually follows the advice of its outside panels, which rarely cast tie votes.
Stephen Dilly, Chiron's chief medical officer, said the company would soon start discussions with the FDA about what "the next study looks like so it can be a post-approval study and not a preapproval study."
While the Pulminiq study that was the focus of yesterday's panel meeting showed that more patients who received the drug lived longer than those who didn't get it, the study didn't show a difference in so-called chronic lung rejection, which was a key measure of the study.
Thirty received Pulminiq, while 26 received a placebo. The dose of Pulminiq varied. After an average of two years, 14 patients in the placebo group died compared with three in the Pulminiq group. However, FDA officials said it wasn't clear whether the drug caused the difference or it was from other factors like the relative health of the patients or other medications they received before the lung transplant.
Renata Albrecht, a division director in the FDA's Office of Drug Evaluation, said it was unusual for the FDA to consider approving a drug based on a small study that was conducted at one place, which, in Puliminiq's case, was at the University of Pittsburgh.
She said new treatments for lung-transplant recipients were urgently needed to raise long-term survival rates. About 70% of heart, liver and kidney transplant patients typically survive more than five years, compared with about 45% of lung-transplant patients.
Pulminiq is an inhaled version of cyclosporine, a drug used for transplant recipients to help keep the body from rejecting the new organs. Researchers speculated that an inhaled version rather than an oral or intravenous version might offer a better treatment for lung-transplant patients.
Researchers at the University of Pittsburgh developed the drug. Chiron later took over the marketing rights to Pulminiq as well as the data from the university.
Write to Jennifer Corbett Dooren at jennifer.corbett-dooren@dowjones.com1
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