GSK Submits FDA New Drug Application for COPD Triple Combination Therapy

GlaxoSmithKline (GSK), together with Innoviva, recently announced GSK submitted a New Drug Application (NDA) with the U.S. FDA for the triple combination therapy FF/UMEC/VI (fluticasone furoate/umeclidinium/vilanterol) to treat chronic obstructive pulmonary disease (COPD).

GSK announced earlier this year that it was planning to advance the timing of the filing with the U.S. Food and Drug Administration from the first half of 2018 – more than a year earlier than expected.

The FF/UMEC/VI combo therapy combines an inhaled corticosteroid (ICS), fluticasone furoate; a long-acting muscarinic antagonist (LAMA), umeclidinium; and a long-acting beta2-adrenergic agonist (LABA), vilanterol.

FF/UMEC/VI was developed to be administered once a day at 100/62.5/25 mcg, respectively, through GSK’s Ellipta dry powder inhaler.

The NDA regulatory submission is based on data from the FF/UMEC/VI development program, as well as on studies with FF, UMEC and VI as single therapies or in combination for the maintenance and treatment of COPD, chronic bronchitis and emphysema.

“COPD is a progressive disease and its impact on patients can worsen over time,” Dave Allen, head of respiratory research and development at GSK, said in a press release.

Taking into account the recently updated Global Strategy for the Diagnosis, Management and Prevention of COPD, Global Initiative for Chronic Obstructive Lung Disease (GOLD 2017), Allen said that for patients with advanced disease, “multiple therapies such as ICS/LAMA/LABA combinations 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.

GSK is also planning to file a regulatory submission with the European Union soon, as well as with other countries’ regulatory agencies in early 2017. The triple combination therapy is not yet approved for any indication in any country.

“We are delighted that the U.S. submission has been achieved some 18 months earlier than planned. 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,” Innoviva CEO Mike Aguiar said.