FDA审议团计划审查礼来公司治疗败血病的药物
WASHINGTON (Reuters Health) - Expert advisors to the US Food and Drug Administration (FDA) are scheduled to review on Tuesday an Eli Lilly and Co. application for a experimental treatment that may significantly reduce the death rate from hospital-acquired blood-borne infections.
The FDA's Anti-Infective drugs Advisory Committee will consider Eli Lilly's biologics license application (BLA) for Xigris (drotrecogin alfa, human activated protein C [rhAPC]), an experimental treatment for sepsis.
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The panel meeting originally was set for September 12, but was postponed due to the September 11 attacks on New York City and Washington DC.
If approved, Xigris would be the first FDA-approved treatment for the condition, which is a systemic infection characterized by coagulation and inflammation that can lead to organ failure. Sepsis is often triggered by bacteria on catheters or surgical instruments.
If approved, Xigris is also expected to fuel Eli Lilly's post-Prozac (fluoxetine) growth. Analysts believe that annual sales of Xigris should surpass $1 billion, and in effect, provide a new engine of growth for the Indianapolis, Indiana-based drugmaker, which lost the patent protection for its blockbuster anti-depressant earlier this summer.
, 百拇医药
Prior to the scheduled September meeting, FDA officials released documents saying that the drug appeared effective. In clinical trials, FDA medical reviewers said that Xigris appeared to reduce mortality by 6% compared with placebo, although with less effect in those patients less than 50 years of age.
But review of the safety data also revealed a higher rate of bleeding-related adverse events, including four deaths, as well as a significant change in mortality rates potentially due to a change in the study design approximately half-way through the pivotal clinical trial. Midway through the study, Lilly modified the entry criteria to exclude patients with a high probability of dying from an underlying non-sepsis related condition within the 28-day study period.
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As a result, the FDA is expected to ask its advisors if they believe the data presented accurately defined the intended patient population and whether the use of the drug would be appropriate for all patients.
Because the mortality benefit was less evident in younger patients and those patients with a better chance of survival, the FDA is also expected to ask committee members whether they believe further clinical trials are needed to support its use in these less-affected patient populations.
, 百拇医药
Sergio Traversa, a portfolio manager for Merlin Biomed, told Reuters, "I'm sure it's going to be approved. I have no doubt." He added, "And my sense is Xigris is going to be used a lot...There is nothing else" to effectively treat sepsis.
Xigris sales should top $1 billion in 2003 and eventually could be as high as $2.5 billion worldwide, he said. "If it doesn't cross a billion dollars in 2003, there is something wrong," Traversa said.
An estimated 750,000 Americans are diagnosed with sepsis each year, of which about 30% eventually die.
In Monday afternoon trading on the New York Stock Exchange, shares of Lilly were down 0.93 at 77.96., 百拇医药
The FDA's Anti-Infective drugs Advisory Committee will consider Eli Lilly's biologics license application (BLA) for Xigris (drotrecogin alfa, human activated protein C [rhAPC]), an experimental treatment for sepsis.
, 百拇医药
The panel meeting originally was set for September 12, but was postponed due to the September 11 attacks on New York City and Washington DC.
If approved, Xigris would be the first FDA-approved treatment for the condition, which is a systemic infection characterized by coagulation and inflammation that can lead to organ failure. Sepsis is often triggered by bacteria on catheters or surgical instruments.
If approved, Xigris is also expected to fuel Eli Lilly's post-Prozac (fluoxetine) growth. Analysts believe that annual sales of Xigris should surpass $1 billion, and in effect, provide a new engine of growth for the Indianapolis, Indiana-based drugmaker, which lost the patent protection for its blockbuster anti-depressant earlier this summer.
, 百拇医药
Prior to the scheduled September meeting, FDA officials released documents saying that the drug appeared effective. In clinical trials, FDA medical reviewers said that Xigris appeared to reduce mortality by 6% compared with placebo, although with less effect in those patients less than 50 years of age.
But review of the safety data also revealed a higher rate of bleeding-related adverse events, including four deaths, as well as a significant change in mortality rates potentially due to a change in the study design approximately half-way through the pivotal clinical trial. Midway through the study, Lilly modified the entry criteria to exclude patients with a high probability of dying from an underlying non-sepsis related condition within the 28-day study period.
, http://www.100md.com
As a result, the FDA is expected to ask its advisors if they believe the data presented accurately defined the intended patient population and whether the use of the drug would be appropriate for all patients.
Because the mortality benefit was less evident in younger patients and those patients with a better chance of survival, the FDA is also expected to ask committee members whether they believe further clinical trials are needed to support its use in these less-affected patient populations.
, 百拇医药
Sergio Traversa, a portfolio manager for Merlin Biomed, told Reuters, "I'm sure it's going to be approved. I have no doubt." He added, "And my sense is Xigris is going to be used a lot...There is nothing else" to effectively treat sepsis.
Xigris sales should top $1 billion in 2003 and eventually could be as high as $2.5 billion worldwide, he said. "If it doesn't cross a billion dollars in 2003, there is something wrong," Traversa said.
An estimated 750,000 Americans are diagnosed with sepsis each year, of which about 30% eventually die.
In Monday afternoon trading on the New York Stock Exchange, shares of Lilly were down 0.93 at 77.96., 百拇医药