FDA panel split on Xigris

An FDA advisory committee on Tuesday rendered a confusing judgement about the safety and efficacy of Xigris drotrecogin alfa from Eli Lilly (LLY ) as a treatment for severe sepsis in adults, expressing strong concerns about the conduct of the Phase III trial and optimism about the compound's potential benefits. According to Thomas Perez, executive secretary of the FDA's Anti-Infective Drugs Advisory Committee, the committee and invited consultants were evenly divided, voting 10-10 on whether the available data support approval of Xigris. Several of the votes, however, were ambiguous and only eight of the votes endorsing the safety and efficacy of Xigris were firm.

The committee's concerns about Xigris centered on LLY's decision to modify the protocol and product manufacturing method midway through the Phase III trial; the difficulty of running a post-approval placebo-controlled trial; and data suggesting that patients who survived to the end of the trial may have had poor quality of life. "I am concerned there was a change in the drug in the middle of the trial and a change in the patient criteria," said committee member Murray Wittner of Albert Einstein College of Medicine, who voted against approval. ...