U.S. health advisors have voted to
keep GlaxoSmithKline Plc’s diabetes drug Avandia on the market with additional
warnings, easing a threat of further litigation that could have followed a ban.
The 33-member panel of outside
experts convened by the U.S. Food and Drug Administration cast 20 votes for
various options that would allow Avandia to stay on the market despite concerns
over associated heart risks.
Only 12 members voted to recommend
that the FDA withdraw the pill. There was one abstention.
The agency will make the final
decision in the coming months but usually follows the advice of its advisory
“In general it’s a positive
for Glaxo,” said Les Funtleyder, analyst with Miller Tabak & Co, but
added that fewer doctors were likely to use Avandia in future.
The pill was once Glaxo’s
second-biggest drug at $3 billion a year but its sales have plunged since
safety fears erupted three years ago.
Avandia’s U.S. sales of $663
million in 2009 were just 1.5 per cent of Glaxo’s revenues, but investors’ real
concerns were that the company could face more lawsuits if the drug was forced
from the market.
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.
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 “inconclusive.”
“If the drug is not pulled
from the market, we do not expect a spike in litigation costs for
GlaxoSmithKline,” said Linda Bannister, an analyst with Edward Jones.
The panel voted that there was an
increased concern about heart attacks with Avandia versus other diabetes drugs
including class rival Actos by Takeda Pharmaceutical Co.
But the panel voted against finding
a greater risk of death with Avandia.
The panel also 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.