A Food and Drug Administration panel voted to recommend approval of a sedative proposed by Eisai Co., but panel members stressed they would like to see more data on how the drug will affect older and obese people.
The FDA can still decide not to approve the drug, but it generally follows its panels' advice. The FDA is supposed to make a decision July 26. Six panel members voted to recommend approval, three voted against, and one abstained.
Eisai is seeking FDA approval of fospropofol disodium, a sedative-hypnotic agent for use in patients undergoing diagnostic or therapeutic procedures such as colonoscopies. Tokyo-based Eisai inherited the drug through its $3.9 billion acquisition of MGI Pharma of Minneapolis in January.
Fospropofol was developed based on the hypothesis it would produce a slow onset of sedation that would reduce the likelihood of sudden and unexpected general anesthesia, the FDA said. Some sedatives in common use, such as propofol, have been associated with inducing general anesthesia. Doctors try to avoid general anesthesia for certain procedures because it carries risks including breathing difficulties.
Several doctors said during a public-comment part of the meeting that the sedative would fill a "gap" in hospitals and clinical offices that don't have enough people trained in general anesthesia. Eisai's drug is targeted at patients who need minimum to moderate sedation.
The majority of the panel members said Eisai didn't show sufficient evidence that fospropofol disodium can be administered safely by those not trained in general anesthesia.
Panel member Michael Epstein said there have been enough studies on propofol, and he added that those not trained in general anesthesia could safely administer Eisai's sedative.
Eisai officials said patients and physicians appear to prefer fospropofol to other sedatives because the recovery time is quicker than with other drugs.
Jeffrey R. Kirsch and Susan Krivacic, two of three panel members who voted against recommending approval, said they would like to see more tests of the sedative on high-risk patients, such as the obese or those over 65.
Mary Lynne Hedley, an executive vice president at Eisai, said the panel's decision "means more choice for physicians and patients." <<
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