SmithKline's Diabetes Pill Avandia Wins U.S. Approval (Update1)
Bloomberg News
May 25, 1999, 7:39 p.m. ET
SmithKline's Diabetes Pill Avandia Wins U.S. Approval (Update1)
(Adds company comment, background in 3rd, 4th paragraphs.)
Washington, May 25 (Bloomberg) -- SmithKline Beecham Plc
said its diabetes pill Avandia won U.S. approval, giving the U.K.
drugmaker a jump on a new rival medicine that's also vying to
grab market share from Warner-Lambert Co.'s similar Rezulin.
The U.S. Food and Drug Administration approved use of the
SmithKline drug alone or in combination with Bristol-Myers Squibb
Co.'s diabetes medicine, Glucophage, the company said. The FDA
also is reviewing Actos, a drug from Japan's Takeda Chemical that
Eli Lilly & Co. will market in the U.S.
Analysts expect doctors to begin prescribing Avandia rather
than Rezulin because Rezulin has been linked to about 35 cases of
death and serious liver damage. More than 1.5 million diabetics
have tried Rezulin since 1997. SmithKline intends to lose no time
getting Avandia to the U.S. market ahead of Actos.
''We plan on making the product commercially available in
the next few days,'' Chief Executive Jan Leschly said in a
statement.
Early research suggests Avandia and Actos are less likely to
cause liver damage than is Rezulin, a drug that Warner-Lambert
licenses from Japan's Sankyo Co.
SmithKline will work with Bristol-Myers to market Avandia.
Analysts say Avandia and Actos could both achieve sales of more
than $1 billion a year in what could become a $5-billion-a-year
market for diabetes treatments.
FDA approval of Avandia was expected today.
SmithKline Beecham's American depositary receipts rose 15/16
to 62 1/8. Morris Plains, New Jersey-based Warner-Lambert fell
3/8 to 63 1/2.
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