* 20 members of 33-strong panel vote to keep on mkt
* Panel stance seen easing risk of further litigation
* But Avandia sales seen declining further
* Critics still hope FDA will move to withdraw Avandia
* Glaxo shares close 1.8 pct higher in New York
(Adds further reaction, edits throughout)
By Lisa Richwine and Susan Heavey
GAITHERSBURG, Md, July 14 GlaxoSmithKline Plc's
(GSK.L) diabetes drug Avandia should be allowed to stay on the
market but with additional warnings, U.S. health advisers
recommended on Wednesday, easing a threat of further costly
litigation that could have followed a ban.
A majority of the 33-member panel of outside experts found
data raised concerns about heart attacks associated with the
widely used pill, but not enough to warrant its withdrawal from
The Food and Drug Administration will make the final
decision in the coming months and the agency usually follows
recommendations from its advisory committees.
But some opponents of the drug said the panel voiced enough
concerns that the FDA could still seek Avandia's removal.
Even if the panel's recommendation lifts a legal cloud for
Glaxo, analysts and doctors predicted further declines in sales
of Avandia as patients defect to alternatives, including Takeda
Pharmaceutical Co's (4502.T) Actos.
Instant view [ID:nN14151765]
Q&A: Should Avandia be pulled? [ID:nN14158520]
ReutersGraphic showing Avandia sales vs Actos:
The pill was once Glaxo's second-biggest drug at $3 billion
a year but its sales plunged to $1.18 billion in 2009,
equivalent to 2.7 percent of Glaxo's group sales.
"Patients aren't dummies; they'll read the papers and know
there's another drug that's similar, called Actos, that does
not have restrictions," said Dr. Jacob Warman, Chief of
Endocrinology at The Brooklyn Hospital Center.
U.S.-listed shares of Britain-based Glaxo (GSK.N) closed up
1.8 percent on the New York Stock Exchange after the vote and
one analyst predicted further gains in London on Thursday.
Mike Ward of Ambrian Partners in London said the panel
decision drew the teeth from litigants hoping for a nasty vote
against Glaxo. "I think Glaxo shares will get a nice bounce in
London in the morning."
The debate on Avandia's safety has raged since warnings
were placed on the drug in 2007 saying some research linked the
drug to a higher heart attack risk but the data was
The advisory panel heard two days of sharply conflicting
opinions from inside and outside the FDA, and reviewed hundreds
of pages of data, before coming to its decision.
Its members cast 20 votes for various options that would
allow Avandia to stay on the market. Only 12 members voted to
recommend that the FDA withdraw the pill, and there was one
A detailed breakdown of the voting showed 10 votes cast for
continued marketing of Avandia with additional warnings and
restrictions on use.
Seven voted for placing additional warnings on the drug and
three votes for marketing with the current label.
Zero votes were cast for Glaxo's request to remove the
existing warning about possible risk of heart attack.
The panel also voted to recommend continuation of a trial
called Tide that compares Glaxo's Avandia with Takeda's Actos.
Some critics of Avandia had argued there was enough evidence
against Avandia that the trial should be abandoned.
Glaxo said it would continue to work with the FDA in the
best interest of diabetes patients.
"Patients taking Avandia should speak with their physician
about their treatment and any questions they may have regarding
the safety of the medicine," Dr. Ellen Strahlman, Glaxo's Chief
Medical Officer, said in a statement.
Steve Nissen, a cardiologist at the Cleveland Clinic who
presented data at the meeting that showed an increased heart
risk with Avandia, said the panel gave the FDA enough cause to
seek the drug's removal.
"I think they gave the leadership of the FDA enough
ammunition to withdraw if they want to withdraw," he said.
Representative Rosa DeLauro, a sharp critic of the FDA's
handling of drug risks, said the panel vote was "gravely
disappointing and raises serious questions as to whether the
science was presented in an unbiased manner." She said Avandia
should be removed from the market.
Concerns about the medicine's adverse impact on the heart
have triggered a slew of lawsuits in the United States.
On Tuesday, Glaxo agreed to pay $460 million to settle
thousands of lawsuits over Avandia, Bloomberg reported, citing
people familiar with the settlements.
Glaxo will settle about 10,000 suits for an average of
$46,000 each, Bloomberg said. A source familiar with the
litigation told Reuters that at least 2,500 claims out of as
many as 14,000 have been settled.
(Reporting by Lisa Richwine and Susan Heavey; Additional
reporting by Lewis Krauskopf, Grant McCool and Ransdell Pierson
in New York and Ben Hirschler in London; Editing by Tim