seeks U.S. approval for triple lung drug
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[November 21, 2016]
LONDON (Reuters) - 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.
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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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