GlaxoSmithKline files for triple COPD therapy 18 months early

GlaxoSmithKline has filed a US regulatory submission for a new three-drug inhaler treatment for patients with chronic obstructive pulmonary diseases such as chronic bronchitis and emphysema.

The filing was achieved around 18 months earlier than originally planned, with a regulatory submission in the EU also planned in the coming weeks, the company said.

Delivered via the Ellipta dry-powder inhaler, the therapy comprises three medicines: fluticasone furoate, an inhaled corticosteroid; umeclidinium, a long-acting muscarinic antagonist; and vilanterol, a long-acting beta2-adrenergic agonist.

GSK's head of respiratory, Dave Allen, pointed out that COPD is a progressive disease and its impact on patients can worsen over time, with recent research highlighting that patients with advanced disease, multiple therapies such as the above combination are often required and are typically delivered via two or more inhalers with potentially differing dose regimens.

"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," he said.

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