2nd Jun 2016 06:23
LONDON (Alliance News) - GlaxoSmithKline PLC on Thursday said it has decided to bring forward the plan to file a new drug application in the US for its treatment of chronic obstructive pulmonary disease (COPD), following discussions with authorities and its partner.
GlaxoSmithKline and its partner, San Francisco-based Innoviva Inc, plans to submit a new drug application covering the once-daily, closed triple combination therapy comprised of three molecules, fluticasone furoate, umeclidinium and vilanterol, which are inhaled by patients suffering from COPD.
Glaxo said it will now submit that application at the end of 2016 rather than in the first half of 2018 as originally planned, adding it decided to accelerate the application following discussions with the US Food & Drug Administration.
GlaxoSmithKline said it expects to submit an EU regulatory submission also by the end of 2016.
By Joshua Warner; [email protected]; @JoshAlliance
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