Application for Triple-Drug, Single-Inhaler COPD Treatment Submitted to FDA

GSK files U.S. regulatory submission for once-daily therapy

GlaxoSmithKline (GSK) has submitted an application to the FDA for the once-daily, closed triple combination therapy fluticasone furoate/umeclidinium/vilanterol (100 mcg/62.5 mcg/25 mcg) for patients with chronic obstructive pulmonary disease (COPD), according to GSK and Innoviva, Inc.

The three medicines—fluticasone furoate, an inhaled corticosteroid; umeclidinium, a long-acting muscarinic antagonist; and vilanterol, a long-acting beta2-adrenergic agonist—would be delivered using GSK’s proprietary dry powder inhaler.

This regulatory submission comprises a new drug application for the maintenance treatment of patients with COPD, including chronic bronchitis and emphysema. It is based on data from the closed triple combination therapy development program, as well as data from studies with the three drugs either alone or in combination.

COPD is a progressive disease, and its impact on patients can worsen over time. The recently updated COPD strategy of the Global Initiative for Chronic Obstructive Lung Disease notes that multiple therapies using different drugs in combination are often required for patients with advanced disease.

These drugs “are typically delivered via two or more inhalers with potentially differing dose regimens,” said Dave Allen, head of respiratory research and development for GSK. “This first 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.”

Earlier this year, the product’s developers announced plans to bring forward the timing of the U.S. filing from the first half of 2018. A regulatory filing in the European Union is planned in the coming weeks and is expected to be followed by submissions in other countries beginning in 2017. The closed triple combination of the three drugs is not approved for use anywhere in the world.

Source: GSK; November 21, 2016.