Panel says 3 asthma drugs should stay on market

By Lisa Richwine

GAITHERSBURG, Md. (Reuters) – Three GlaxoSmithKline Plc
and Novartis AG asthma drugs are safe enough to stay on the
market amid concerns they raise the risk of severe asthma
attacks in rare cases, a U.S. advisory panel unanimously said
on Wednesday.

Glaxo’s drugs Serevent and Advair already come with “black
box” warnings about one study showing Serevent patients had a
higher, albeit small, risk of life-threatening asthma attacks
and deaths.

Novartis’ medicine Foradil, part of the same category of
drugs, should carry a similar warning about the study, the Food
and Drug Administration advisory panel ruled.

“Until proven otherwise, we have to make ourselves believe
(Foradil) may act the same way,” said panel member Dr. Steven
Gay, medical director of critical care medicine at the
University of Michigan Health System.

Novartis said Foradil, which Schering-Plough Corp. markets
in the United States, acted differently than the Glaxo drugs
and may be safer. But Novartis said it would “work with the FDA
to finalize appropriate language” if the agency asked for a new
warning.

The FDA usually follows recommendations from its advisory
panels.

Asthma is a chronic lung disease that afflicts about 15
million Americans, nearly 5 million of them children. The
disease can cause episodes of wheezing, coughing and breathing
difficulty. Severe asthma attacks can kill.

Serevent, Advair and Foradil are inhaled drugs known as
long-acting beta agonists that patients take daily to relax
bronchial muscles and prevent asthma attacks.

Panel members said the drugs’ benefits of controlling
asthma symptoms and improving lung function outweighed the
small possibility of a life-threatening asthma attack.

In a Glaxo study detailed on the drug labels, there were 13
deaths among about 13,000 patients treated for 28 weeks with
Serevent, compared with three deaths among about 13,000 people
given a placebo.

Severe asthma attacks also were seen when Foradil was given
at a higher dose that the FDA refused to approve. Another study
done after approval was too small to draw conclusions about the
safety concern, FDA reviewers said.

Advair is a combination of Serevent, known generically as
salmeterol, and another asthma drug. Global Advair sales were
$4.5 billion in 2004, making it Glaxo’s top-selling product.
Serevent sales were $639 million.

Foradil’s global sales were $320 million in 2004. The
generic name for Foradil is formoterol.