LONDON Nov 21 GlaxoSmithKline said on
Monday it had filed its new three-in-one inhaled lung drug for
U.S. approval, putting it on track to reach the market ahead of
rivals in 2017, assuming it wins a green light.
Britain's biggest drugmaker is vying with competitors
including AstraZeneca and Novartis to develop
so-called "closed triple" therapies, offering a single inhaler
for patients with chronic obstructive pulmonary disease (COPD).
GSK is currently facing falling sales of its older dual
therapy inhaler Advair and views the triple as a big
opportunity. Outgoing Chief Executive Andrew Witty has said it
could be an "absolute clincher" for its respiratory business.
The idea is to use three different mechanisms of action to
help 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 forward
plans to seek regulatory approved in the United States following
discussions with the Food and Drug Administration.
The new once-daily drug will be filed in the European Union
in the coming weeks, with submissions in other countries
beginning 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)