Subject: FDA Panel Clears Drug For Alzheimer's 
Date: Published: 3/19/93 (62 lines)
Source: Wall Street Journal. Copyright Dow Jones & Co. Inc.

    Technology & Medicine:
    FDA Panel
    Clears Drug
    For Alzheimer's
    ----
    By Rose Gutfeld
    Staff Reporter of The Wall Street Journal

    WASHINGTON -- On its third try, Warner-Lambert Co. has won a
 favorable recommendation from a Food and Drug Administration
 advisory committee for its Alzheimer's drug Cognex.
    At a day-long meeting yesterday, the panel voted, 10-0, to
 recommend that the FDA approve the drug for treating symptoms of the
 mind-robbing disease, which afflicts about four million Americans.
 FDA officials said approval by the agency could occur within as
 short a time as a month and a half; if approved, it would be the
 first time the government has given the nod for a drug to treat
 Alzheimer's.
    The speed with which the agency is moving to review the company's
 application reflects FDA Commissioner David Kessler's pledge to
 evaluate drugs for Alzheimer's with the same urgency it gives to
 drugs for cancer and AIDS.  One of the studies that the panel
 evaluated yesterday was just completed in January.
    At a news conference, FDA officials promised that additional
 Alzheimer's drugs in the pipeline would get similar treatment.
 "We're aggressively working with sponsors to develop new drugs,"
 said Carl Peck, director of the agency's Center for Drug Evaluation
 and Research.  "We have revved up our review staff."
    The recommendation, by the agency's Peripheral and Central
 Nervous System Drugs Advisory Committee was a coup for
 Warner-Lambert's Parke Davis division, which was turned down twice
 by the panel in 1991.  At that time, the committee said that clinical
 studies of the drug failed to show it provided a benefit that
 outweighed possible health risks.
    In its latest bid, the company presented evidence from two new
 studies.  The committee determined these studies demonstrated that
 the drug provides a significant, if small, benefit.  Nor does it
 cause serious adverse effects.  Among other points, an increase in
 liver enzymes that had appeared worrisome in the earlier studies now
 seemed manageable.  Such a rise can indicate potential liver damage.
    At the same time, the experts spent much of the day agonizing
 over the modest benefits of the medication.  The drug, which is
 designed to treat mild-to-moderate symptoms of the illness, doesn't
 affect the overall progression of the disease.  Moreover, the studies
 didn't show hopedfor dramatic improvements in patients.
    The final vote, however, partly reflected a desire to give
 patients every chance possible.  "I can't think of why someone
 doesn't at least have the chance to go down kicking," said Dennis
 Choi, of Washington University, St. Louis.
    Warner-Lambert hasn't yet announced how much it will charge for
 the drug, if it's approved.  Under a special program in effect since
 late-1991, the company has been supplying the drug to about 6,000
 patients for $3 a day.

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