GlaxoSmithKline and Innoviva, Inc. may have gotten the jump on competitors with a triple combination medication for patients with advanced chronic obstructive pulmonary disease (COPD). Last week, the companies announced, after talks with the FDA, that they were accelerating plans to file a new drug application for a once-daily closed triple combination therapy consisting of fluticasone furoate, umeclidinium, and vilanterol (FF/UMEC/VI) for a COPD indication. The regulatory submission is now anticipated by the end of 2016, rather than during the first half of 2018, as previously planned.
FF is an inhaled corticosteroid (ICS); UMEC is an anticholinergic agent, also known as a long-acting muscarinic antagonist (LAMA); and VI is a long-acting beta2-adrenergic agonist (LABA). The triple therapy, codeveloped by GSK and Innoviva, will be delivered once-daily in GSK’s Ellipta dry-powder inhaler.
GSK already has two ICS/LABA combination products for asthma and COPD––Advair Diskus (FF/salmeterol) and Breo Ellipta (FF/VI). The company also markets a LAMA/LABA combination product, Anoro Ellipta (UMEC/VI), for COPD.
An ongoing clinical program is comparing the efficacy and safety of the closed triple therapy with that of existing COPD treatments in two studies.
The FULFIL (Lung Function and Quality of Life Assessment in COPD with Closed Triple Therapy) trial is assessing whether closed triple therapy with FF/UMEC/VI (100 mcg/62.5 mcg/25 mcg) can improve lung function and health-related quality of life compared with budesonide/formoterol (400 mcg/12 mcg) (Symbicort, AstraZeneca), a twice-daily ICS/LABA combination delivered via the Turbohaler inhaler. The phase 3, international, 24-week, randomized, double-blind, double-dummy, parallel-group study began in January 2015 and was completed in April 2016. The total enrollment was 1,811 patients. A subset of approximately 400 patients have remained on blinded study treatment for up to 52 weeks to provide additional long-term safety data.
The IMPACT (Informing the Pathway of COPD Treatment) study, which began in June 2014 and is expected to be completed in July 2017, is investigating whether FF/UMEC/VI can reduce the rate of COPD exacerbations compared with two once-daily dual therapies from GSK’s existing portfolio: FF/VI and UMEC/VI. The phase 3, 52-week, randomized, double-blind, parallel-group study will randomly assign an estimated 10,000 adults (40 years of age and older) to receive one of the following treatments: FF/UMEC/VI 100 mcg/62.5 mcg/25 mcg once daily (QD); FF/VI 100 mcg/25 mcg QD; or UMEC/VI 62.5 mcg/25 mcg QD.
Sources: FiercePharma; June 8, 2016; and GlaxoSmithKline; June 2, 2016.