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GlaxoSmithKline seeks U.S. approval for triple lung drug

Mon, 21st Nov 2016 08:00

LONDON, Nov 21 (Reuters) - GlaxoSmithKline said onMonday it had filed its new three-in-one inhaled lung drug forU.S. approval, putting it on track to reach the market ahead ofrivals in 2017, assuming it wins a green light.

Britain's biggest drugmaker is vying with competitorsincluding AstraZeneca and Novartis to developso-called "closed triple" therapies, offering a single inhalerfor patients with chronic obstructive pulmonary disease (COPD).

GSK is currently facing falling sales of its older dualtherapy inhaler Advair and views the triple as a bigopportunity. Outgoing Chief Executive Andrew Witty has said itcould be an "absolute clincher" for its respiratory business.

The idea is to use three different mechanisms of action tohelp open the airways of patients with more severe disease,rather than just two used at present.

GSK had said earlier this year it intended to bring forwardplans to seek regulatory approved in the United States followingdiscussions with the Food and Drug Administration.

The new once-daily drug will be filed in the European Unionin the coming weeks, with submissions in other countriesbeginning in 2017.

GSK's triple inhaler, which is being developed with Innoviva, combines fluticasone, umeclidinium and vilanterol. (Reporting by Ben Hirschler; Editing by Mark Potter)

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