BioCentury
ARTICLE | Company News

FDA questions on Lilly's Xigris

October 15, 2001 7:00 AM UTC

FDA's Anti-Infective Drugs Advisory Committee will consider on Tuesday LLY's NDA for Xigris drotrecogin alfa to treat sepsis. The meeting, originally scheduled for Sept. 12, was rescheduled because of the Sept. 11 attacks (see BioCentury, Sept. 17). Although FDA review documents conclude that LLY has demonstrated safety and efficacy, the agency still has concerns about Xigris, according to questions for an advisory committee released on Monday. A change in eligibility criteria midway through the pivotal Phase III Xigris trial that reduced the number of patients with a high probability of dying from a non-sepsis related condition led to dramatically better efficacy results. FDA plans to ask the Anti-Infective Advisory Committee on Tuesday if the entry criteria "define a population appropriately described as having severe sepsis." ...