GSK, Innoviva announce US nod for Trelegy Ellipta

GlaxoSmithKline and Innoviva have bagged a green light in the US for the novel triple therapy inhaler Trelegy Ellipta, opening the door to a new treatment option for patients with Chronic Obstructive Pulmonary Disorder (COPD).

Trelegy Ellipta combines three active molecules - fluticasone furoate, umeclidinium, vilanterol (FF/UMEC/VI), found in Breo Ellipta and Incruse Ellipta - in the same inhaler, and is the first once-daily triple medicine for COPD to hit the market.

It is also the first time a combination of an inhaled corticosteroid (ICS), long-acting beta2-adrenergic agonist (LABA) and long-acting muscarinic antagonist - three commonly use classes of medicine for respiratory conditions - has been approved for use in a single inhaler.

The US Food and Drug Administration has cleared Trelegy Ellipta for the long-term, once-daily, maintenance treatment of COPD, including chronic bronchitis and/or emphysema, in patients who are on a fixed-dose combination of FF and VI for airflow obstruction and reducing exacerbations in whom additional treatment of airflow obstruction is desired, or for patients who are already receiving umeclidinium and a fixed-dose combination of FF/VI.

"This approval represents a significant therapeutic convenience for those appropriate patients already on Breo Ellipta, that require additional bronchodilation or for those patients already on a combination of Breo Ellipta and Incruse Ellipta," noted Mike Aguiar, Innoviva’s chief executive.

The decision follows a recent marketing recommendation by the European Medicines Agency’s CHMP, based on data from the FULFIL study showing statistically significant improvements with the triple therapy compared with the dual therapy Symbicort Turbohaler (budesonide/formoterol) in both lung function, as measured by trough FEV1 (+171 mL), and health-related quality of life, as measured by the St. George's Respiratory Questionnaire (-6.6 versus -4.3, respectively).

Also, the study showed a statistically significant and clinically meaningful reduction in the annual rate of moderate/severe exacerbations with FF/UMEC/VI compared to Symbicort Turbohaler, with closed triple therapy showing a 35 percent reduction based on data up to 24 weeks and a 44 percent reduction in the subset of patients that received treatment for up to 52 weeks.

COPD is a common but serious lung disease that is thought to affect 384 million people worldwide.

GSK said it would launch the drug in the US "shortly".