FDA staff finds no new safety problems with Glaxo's asthma drug

[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.

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.

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.

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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