GSK and Innoviva in new COPD filing

21 November 2016

GlaxoSmithKline (LSE: GSK) has filed a regulatory submission with the US Food and Drug Administration (FDA) for the once-daily, closed triple combination therapy fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI 100/62.5/25 mcg) for chronic obstructive pulmonary disease (COPD).

The UK pharma major and its US partner Innoviva (Nasdaq: INVA) announced earlier this year their plans to bring forward the timing of the US filing from the first half of 2018.

This closed triple combination therapy comprises three medicines, namely fluticasone furoate, an inhaled corticosteroid (ICS), umeclidinium, a long-acting muscarinic antagonist (LAMA) and vilanterol, a long-acting beta2-adrenergic agonist (LABA), delivered once-daily in GSK’s Ellipta dry powder inhaler.

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