NEW YORK, April 18 U.S. regulators are
considering ending a safety study on GlaxoSmithKline's (GSK.L)
diabetes drug Avandia, the Wall Street Journal reported on
Sunday, saying the move could also jeopardize the drug's
presence in the U.S market.
Avandia has been in the spotlight because of concerns that
the drug increases heart attack risks. U.S. Senators Max Baucus
and Charles Grassley released a report on the drug in February
as well as internal FDA documents, including a 2008 memo from
two FDA drug safety reviewers who recommended pulling the drug
from the U.S. market.
Glaxo has said the scientific evidence did not establish
that Avandia increased heart attack risks and added it had been
open in providing information about the drug.
According to the Wall Street Journal report, FDA
commissioner Margaret Hamburg wrote a letter to Grassley in
late March saying that the agency is reassessing a trial that
compares the drug to a drug made by Takeda Pharmaceutical Co
called Actos. That trial is also called the TIDE trial,
according to the Journal.
FDA Principal Deputy Commissioner Joshua Sharfstein told
the Journal that the decision on the trial "cannot be de-linked
from the agency's view of Avandia."
Sharfstein said no decision had been made on the trial --
the FDA has asked a government scientific panel to review the
ethics of head-to-head trials, the Journal said.
In late March, Saudi Arabia's Food and Drug Authority has
suspended Avandia for six months, becoming the first healthcare
regulator to take such action. The Saudi FDA argued that the
potential heart risks of the drug outweigh its benefits.
GlaxoSmithKline and Senator Grassley could not be
immediately reached for comment.
(Reporting by Michael Erman; Editing by Bernard Orr)