* Gilead seeking approval for aztreonam
Regulatory News
* U.S. panel to review drug on Thursday
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NEW YORK, Dec 8 (Reuters) - U.S. Food and Drug Administration staff cited concerns on Tuesday with the design and analysis of clinical studies intended to support the effectiveness of Gilead Sciences Inc's (GILD.O) experimental cystic fibrosis drug.
Gilead, the large U.S. biotechnology company, is seeking approval for its inhaled drug aztreonam for treating respiratory symptoms and pulmonary function in some cystic fibrosis patients.
In looking at Gilead's application ahead of an FDA advisory panel on the medicine on Thursday, FDA staff reviewed two clinical studies designed to support the efficacy of Gilead's aztreonam, a reformulated version of an intravenous antibiotic.
In one study of 211 patients, FDA staff said dropouts due to adverse events and other reasons may have led to biases favoring the Gilead drug. A company analysis of the study also may have been flawed, the staff said.
"There are concerns that assumptions used in the analysis could have been determined retrospectively," the staff said in their 48-page briefing document.
In a second study of 164 patients, staff raised several concerns about a questionnaire used to determine how a patient's symptoms may have been affected during the study.
The problems cited included missing data from incomplete questionnaires, and unclear and vague responses.
"There are several concerns about these questions and the responses," the staff said.
Gilead shares were down 69 cents, or 1.5 percent, at $45.93 in morning trading on Nasdaq.
(Reporting by Lewis Krauskopf, editing by Dave Zimmerman)
Regulatory News
* U.S. panel to review drug on Thursday
<a target=_blank class=ftalternatingbarlinklarge href="http://tinyurl.com/yg6gnv5
">http://tinyurl.com/yg6gnv5
</a>
NEW YORK, Dec 8 (Reuters) - U.S. Food and Drug Administration staff cited concerns on Tuesday with the design and analysis of clinical studies intended to support the effectiveness of Gilead Sciences Inc's (GILD.O) experimental cystic fibrosis drug.
Gilead, the large U.S. biotechnology company, is seeking approval for its inhaled drug aztreonam for treating respiratory symptoms and pulmonary function in some cystic fibrosis patients.
In looking at Gilead's application ahead of an FDA advisory panel on the medicine on Thursday, FDA staff reviewed two clinical studies designed to support the efficacy of Gilead's aztreonam, a reformulated version of an intravenous antibiotic.
In one study of 211 patients, FDA staff said dropouts due to adverse events and other reasons may have led to biases favoring the Gilead drug. A company analysis of the study also may have been flawed, the staff said.
"There are concerns that assumptions used in the analysis could have been determined retrospectively," the staff said in their 48-page briefing document.
In a second study of 164 patients, staff raised several concerns about a questionnaire used to determine how a patient's symptoms may have been affected during the study.
The problems cited included missing data from incomplete questionnaires, and unclear and vague responses.
"There are several concerns about these questions and the responses," the staff said.
Gilead shares were down 69 cents, or 1.5 percent, at $45.93 in morning trading on Nasdaq.
(Reporting by Lewis Krauskopf, editing by Dave Zimmerman)