GSK aims to get triple therapy approved for asthma in US

GlaxoSmithKline and development partner Innoviva have filed a dossier with the FDA, in a bid to get their triple therapy approved to keep asthma at bay. Trelegy (fluticasone furoate/umeclidinium/vilanterol) is already marketed in the US in chronic obstructive pulmonary disease (COPD) – but GSK is chasing this additional indication as an asthma maintenance therapy as it seeks to find a successor to its ageing respiratory drug Advair (fluticasone propionate+salmeterol). Advair is finally losing sales to generic competitors after the FDA finally approved a cheaper rival from Mylan earlier this year, following years of delays because of the regulator’s demanding technical requirements for drug-device combinations. Already approved in COPD, GSK is aiming to get its triple therapy approved in the highly competitive US market. Aside from generic Advair there are a range of other treatments available including injections from GSK, AstraZeneca and Sanofi that aim to reduce the inflammation thought to be the root cause of the disease. With Trelegy, GSK is aiming to give patients the option of controlling their condition with a single daily dose of the three-drug combination therapy, reducing the need for multiple inhalers containing the various drug components.

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