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22 Nov 2016

GSK files US regulatory submission for triple COPD therapy approval

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GlaxoSmithKline and Innoviva have filed for approval in the US of a new once-daily, triple combination therapy for maintenance treatment of patients with chronic obstructive pulmonary disease (COPD), some 18 months earlier than originally planned.

The closed combination consists of three medicines –

  • The inhaled corticosteroid (ICS) fluticasone furoate
  • A long-acting muscarinic antagonist (LAMA) umeclidinium
  • Long-acting beta2-adrenergic agonist (LABA) vilanterol

delivered once-daily in GSK’s Ellipta dry powder inhaler.

The US regulatory submission of the closed triple therapy comprises a New Drug Application for the maintenance treatment of patients with COPD, including chronic bronchitis and emphysema. It is based on data from the closed triple combination therapy development programme, as well as data from studies with FF, UMEC and VI either alone or in combination.

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