FDA
staff finds no new safety problems with Glaxo's asthma
drug
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[March 18, 2015]
(Reuters) - GlaxoSmithKline Plc's
respiratory treatment for chronic breathing problems did not show any
new safety problems while being tested to treat asthma, a preliminary
review by U.S. Food and Drug Administration staff found.
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The review comes two days ahead of a meeting of FDA advisers to
discuss the combination treatment, Breo Ellipta, and recommend
whether it should be approved to treat asthma.
The inhaled drug combination of a corticosteroid and vilanterol is
already approved to treat chronic obstructive pulmonary disease, a
breathing disability that gets worse with time and affects mostly
smokers.
Corticosteroids smoothen the inner surface of breathing pathways.
Vilanterol belongs to a class of compounds called long-acting beta-adrenoceptor
agonists (LABA) that have historically been linked to asthma-related
deaths. Glaxo licensed vilanterol from Theravance Inc in 2002.
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Data showing Breo Ellipta's LABA component delayed the worsening of
asthma symptoms could sway the FDA panel in its favor, analysts from
Robert W. Baird & Co said last week.
The FDA staff said on Tuesday there were no asthma-related deaths in
Breo Ellipta studies it reviewed and that data on asthma-related
hospitalizations were not observed uniformly in the 23 studies that
Glaxo conducted.
The data submitted by Glaxo showed that the safety profile of Breo
Ellipta to treat asthma was similar to that of other combinations of
steroids and LABA compounds, the FDA staff said.
They also said advisers would discuss the fact that the benefit of
adding a LABA compound to a steroid was not demonstrated
consistently in the trials.
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Glaxo has three respiratory treatments on the market with a LABA
compound and each of them carry a warning that the drug could
increase the risk of asthma-related deaths.
This possible side-effect was verified in a study that tested
another one of Glaxo's LABA compounds, salmeterol, against a
placebo.
Salmeterol, which is approved in the United States under the brand
name Serevent Diskus to treat asthma but only in combination with an
inhaled steroid, has been available on the market since 1994.
(Reporting by Vidya L Nathan and Amrutha Penumudi in Bengaluru;
Editing by Savio D'Souza)
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