UPDATE 2-UK wants GSK’s Avandia pulled as EU reviews safety

* UK safety experts want Glaxo’s Avandia pulled from sale

* Regulator’s advisory group says risks outweigh benefits
* European drugs regulators hold special meeting this week

* Glaxo says drug safe, effective when used appropriately

* Glaxo shares fall 1.6 percent, underperforming index

(Adds analyst, Glaxo posting audio recording of Nissen meeting)

By Ben Hirschler and Kate Kelland

LONDON, Sept 6 (BestGrowthStock) – GlaxoSmithKline’s (GSK.L: )
diabetes drug Avandia should be pulled from sale because of
concerns about heart risks, British drug regulators said on
Monday ahead of a special European meeting on the drug’s safety.

The strong line from safety experts in the drugmaker’s home
market is a fresh blow to a medicine that was once Glaxo’s
second biggest seller but has become a liability since being
linked to increased heart attack risk in 2007.

The Medicines and Healthcare products Regulatory Agency
(MHRA) said it believed the risks of Avandia, known generically
as rosiglitazone, outweighed its benefits and that “it no longer
has a place on the UK market”.

Glaxo shares fell 1.6 percent to 1,248.5 pence by 1220 GMT,
underperforming a 0.3 percent rise in leading London stocks
(.FTSE: ).
Spokesman Stephen Hallworth said the MHRA had put forward
its position “robustly” to the European Medicines Agency (EMA)
and would highlight its concerns again at a special meeting on
the drug’s future this week.

The EMA — the decentralised European body responsible for
licensing Avandia in 2000 — will hold an extraordinary expert
meeting on Sept. 8 to review the drug’s safety before finalising
its position at its next scheduled meeting on Sept. 20 to 23.

London-based EMA said the additional meeting was necessary
because of the complexity of the data being assessed.

The British Medical Journal (BMJ) and some leading doctors
attacked the tardy response, calling for Avandia to be pulled
off the market immediately and saying it should never have been
licensed in the first place.

CALL FOR WITHDRAWAL IN JULY

British regulators’ concerns about Avandia came to light
following a BMJ investigation that found out the Commission on
Human Medicines — an independent working group advising British
ministers — had recommended the withdrawal of Avandia in July.

A MHRA letter sent to doctors on July 26 merely advised them
to “consider alternative treatments where appropriate”.

Dr Deborah Cohen, who led the BMJ investigation, said the
letter was not clear enough, and the MHRA should have informed
doctors of the commission’s full opinion.

“Medicine is all about benefits versus risks,” she said in a
telephone interview. “And if a group of experts in drug safety
believes the risks outweigh the benefits, that’s an important
message that would inform doctors when they’re prescribing.”

The BMJ’s editor, Dr Fiona Godlee, told Reuters: “The time
has now come for this drug to be withdrawn from the market.”

Avandia used to be Glaxo’s second-biggest drug, selling $3
billion in 2006 until health concerns emerged. Its sales plunged
to $1.2 billion in 2009, or some 2.7 percent of group sales, as
many doctors switched to Takeda’s (4502.T: ) rival drug Actos.

A withdrawal of European approval would be a blow but not a
disaster for Glaxo, given the drug is anyway set to lose patent
protection shortly, said Mike Ward, industry analyst at Ambrian
Partners. Avandia’s U.S. patent cover runs to 2012.

<^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^

Graphic of Avandia sales vs Actos:

http://link.reuters.com/num57m

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John Yudkin of University College London said the problems
with Avandia, which will also be the subject of a BBC Panorama
programme on Monday, highlighted clear shortfalls in the
regulatory system.

“Ten years after the release of rosiglitazone, we still
cannot accurately quantify the harm to which we were exposing
our patients,” he said. “If the regulatory bodies do not insist
on clear evidence of greater benefit than harm, they are failing
in their basic purpose.”

In a move to pre-empt damage from the Panorama programme,
Glaxo posted on its website an audio recording of a 2007 meeting
with Dr Steve Nissen, the U.S. cardiologist who first raised the
alarm about Avandia and heart attack risks
http://www.gsk.com/media/avandia-audio.htm.

Glaxo said it had issued a subpoena to obtain a copy of the
recording, which Nissen had made covertly, and had decided to
release it because Panorama’s pre-publicity said it was the
“secret tape the drug company would rather you didn’t hear”.

FDA DECISION

In the United States, health advisers recommended to
regulators on July 14 that Avandia should be allowed to stay on
the market but with additional warnings. [ID:nN14274445]

The Food and Drug Administration is expected to make a final
decision on Avandia later this month and the agency usually
follows recommendations from its advisory committees.

Glaxo said an extensive research programme showed Avandia
was safe and effective when used appropriately according to its
labelling.

The drugmaker has faced a slew of lawsuits in the U.S. but
tried to put the issue behind it in July by taking a record
legal charge of 1.57 billion pounds ($2.4 billion), partly to
settle the bulk of the Avandia claims. [ID:nLDE66E081]

Britain’s Department of Health said it was aware of concerns
about Avandia, but advised patients not to stop taking their
medication without talking to a doctor.

“MHRA has issued guidance to all healthcare professionals
with clear warnings about the associated risks for some
patients,” it said. “Ministers have not been asked to make any
decisions about the licence of Avandia in the UK.”
(Editing by Sharon Lindores)
($1 = 0.6511 pound)

UPDATE 2-UK wants GSK’s Avandia pulled as EU reviews safety