GSK files for FDA approval of inhaled triple-combo therapy for COPD

GlaxoSmithKline (NYSE:GSK) and Innoviva (NSDQ:INVA) said today that GSK filed a regulatory submission with the FDA for the once-daily, closed triple combination therapy fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) for patients with chronic obstructive pulmonary disease.

The triple-combo therapy includes 3 drugs: fluticasone furoate, an inhaled corticosteroid; umeclidinium, a long-acting muscarinic antagonist; vilanterol, a long-acting beta2-adrenergic agonist. The medicines are delivered once-daily using GSK’s Ellipta dry powder inhaler.

GSK submitted a New Drug Application for the maintenance treatment of patients with COPD, including chronic bronchitis and emphysema. The company plans to file for approval in the EU in the coming weeks and will file in other countries beginning next year.

“COPD is a progressive disease and its impact on patients can worsen over time. As reflected in the recently updated GOLD COPD strategy, for those patients with advanced disease, multiple therapies such as ICS/LAMA/LABA combinations are often required and are typically delivered via 2 or more inhalers with potentially differing dose regimens,” GSK’s head of respiratory R&D Dave Allen said in prepared remarks. “This 1st regulatory submission of our closed triple therapy brings us a step closer to providing a once-daily treatment in a single Ellipta inhaler as an alternative option for those patients who require multiple therapies.”

“We are delighted that the US submission has been achieved some 18 months earlier than planned,” Innoviva CEO Mike Aguiar added. “If approved, FF/UMEC/VI as a once daily triple combination in a single inhaler could be a meaningful addition to the treatment options available for advanced COPD patients.”

In September, GSK and Innoviva touted results from a Phase III study investigating the triple-combination therapy for patients with chronic obstructive pulmonary disease, and saw that its therapy showed improved lung function and fewer exacerbations compared to patients using AstraZeneca‘s (NYSE:AZN) Symbicort Turbohaler dry powder inhaler.