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.

Trelegy contains fluticasone furoate, an inhaled corticosteroid (ICS), umeclidinium, a long-acting muscarinic antagonist (LAMA); and vilanterol, a long-acting beta2-adrenergic agonist (LABA), delivered in GSK’s Ellipta dry powder inhaler.

GSK’s filing is supported by data from the phase 3 clinical study CAPTAIN, conducted in 2,436 adults with uncontrolled asthma across 15 countries, and positive headline results were reported in May.

The UK pharma’s filing comes during what has turned into a pivotal week in respiratory drug development.

Novartis reported positive results from a two-drug combination therapy under development in asthma, which could be a close competitor to Ellipta should regulators approve it. Chiesi is also developing a triple therapy in asthma and reported encouraging trial results at this week's European Respiratory Society conference.

And this week AstraZeneca reported that it had suffered a setback with its triple therapy in COPD, PT010.

The FDA issued a dreaded complete response letter, rejecting the drug and asking for further clinical trial data to support the filing.

Christopher Corsico, senior vice president of development at GSK said: “Around 30% of asthma patients adherent to ICS/LABA combination therapy still experience symptoms. This filing is an important step towards giving asthma patients an additional treatment option. If approved, this filing would make Trelegy Ellipta the first and only single inhaled triple therapy available for both asthma and COPD in the US.”