And WSJ
FDA Advisers Are Split In Voting on Lilly Drug
By OTESA MIDDLETON and THOMAS M. BURTON
Staff Reporters of THE WALL STREET JOURNAL
WASHINGTON -- An advisory panel to the Food and Drug Administration deadlocked 10-10 Tuesday on whether Eli Lilly & Co.'s much-touted drug Xigris should be approved for treating severe septic infections, which often prove fatal.
Xigris, widely regarded by Wall Street as likely to be Lilly's next blockbuster, had been predicted to win the panel's blessing and ultimately approval from the FDA. The agency typically follows the advice of its panels, but with a tie vote, the federal agency lacks guidance about its course.
Indianapolis-based Lilly, in a news release late Tuesday, said that it was "surprised" by the tie vote and that it still feels "very confident" the FDA will approve the drug. The agency faces a deadline to act by the end of this month.
The advisory group volleyed back and forth on whether the single, large study Lilly submitted proved the drug worked in the sickest of patients. In particular, some members of the panel were concerned about a decision during the clinical trial to exclude patients who clearly died from causes other than sepsis. Without a second study confirming the mortality benefit Lilly sees with the drug, some panelists weren't convinced. Some expressed doubts as to whether survival alone as a measure could truly prove a benefit in patients, since those who survive might still be in intensive care in a vegetative state.
Panelists who supported approval said the modest benefit shown in the study -- a reduction of nearly 20% in the death rate -- was enough, since there are no other drugs specifically endorsed by the FDA for treating sepsis. Sepsis is an infection of the blood that can arise in surgical patients, cancer patients and others; it often results in organ shutdown and death.
Panelist Ellen R. Wald, vice chairman of the department of pediatrics at Children's Hospital of Pittsburgh, said the decision was a tough call.
"This drug was performing well," Dr. Wald said. "If we don't approve it, we will be denying people who can benefit."
News of the panel's decision was released after 4 p.m. Tuesday, at which time Lilly shares were up 94 cents to $79 each in New York Stock Exchange composite trading.
Gordon R. Bernard, the Vanderbilt University professor of medicine who supervised Lilly's clinical trial, said that, contrary to the views of some panel members, "the sickest patients were not excluded" from the trial. He said the intention of the change in clinical-study protocol was "intended to exclude mortality independent of sepsis." He said he thinks the drug nevertheless will be approved by the FDA. |
