GSK to File NDA for Triple-combo COPD Therapy

GlaxoSmithKline has brought forward a plan to file a New Drug Application (NDA) in the US for the once-daily closed triple combination therapy, fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) for patients with COPD, according to a GSK and Innoviva Inc press announcement.

The FF/UMEC/VI therapy is a combination inhaled corticosteroid, long-acting muscarinic antagonist, long-acting beta agonist. GSK and Innoviva say the US regulatory submission is now anticipated by the end of 2016, rather than the first half of 2018, as previously expected.

The NDA for the closed triple combination therapy will comprise data now in hand from the closed triple combination therapy development program, as well as data from studies with FF, UMEC and VI either alone or in combination.

The companies continue to expect an EU regulatory submission of the closed triple combination therapy for COPD by the end of 2016.

The closed triple therapy is a combination of three molecules: fluticasone furoate (FF), an inhaled corticosteroid (ICS), umeclidinium (UMEC), an anti-cholinergic, also known as a long-acting muscarinic antagonist (LAMA) and vilanterol (VI), a long-acting beta₂-adrenergic agonist (LABA) delivered once-daily in GSK’s Ellipta dry powder inhaler.

The ongoing clinical program in patients with COPD comprises two studies investigating the effectiveness and safety of closed triple therapy compared to existing COPD treatments.

• The FULFIL (Lung FUnction and quality of LiFe assessment in COPD with closed trIpLe therapy) study, which began in 2015 and is expected to read out later in 2016 to support EU filing, is assessing whether the closed triple therapy can improve lung function and health-related quality of life compared with Symbicort (budesonide/formoterol), a twice-daily ICS/LABA combination delivered via the Turbohaler inhaler.
• The IMPACT (InforMing the PAthway of COPD Treatment) study, which began in 2014 and is expected to read out in 2017, is investigating whether FF/UMEC/VI can reduce the rate of exacerbations compared with two, once-daily dual therapies from GSK’s existing portfolio: FF/VI, an ICS/LABA combination and UMEC/VI, a LAMA/LABA combination.

The closed triple combination of FF/UMEC/VI is not approved for use anywhere in the world.