FDA Extends Trelegy Ellipta as Maintenance Treatment to Broader Group of COPD Patients

The U.S. Food and Drug Administration (FDA) recently approved an expanded indication for Trelegy Ellipta, meaning the medicine can now be used by doctors there to treat a broader population of chronic obstructive pulmonary disease (COPD) patients.

This new indication is as a once daily, long-term maintenance treatment of airflow obstruction in people with COPD, including those with chronic bronchitis or emphysema.

Airflow obstruction refers to patients with limited airflow or experiencing an acute worsening in respiratory symptoms.

Trelegy Ellipta, co-developed by GlaxoSmithKline (GSK) and Innoviva, is the first COPD treatment to provide a combination of three compounds in a single inhaler, taken in a single inhalation once daily. It contains fluticasone furoate (an inhaled corticosteroid), umeclidinium (a long-acting muscarinic antagonist), and vilanterol (a long-acting beta2-adrenergic agonist), delivered using GSK’s Ellipta dry powder inhaler, developed specifically for COPD.

It was first approved by the FDA as a long-term, once-daily, maintenance treatment for COPD patients on a fixed dose of Breo Ellipta (fluticasone furoate/vilanterol) who need additional help with airflow obstruction. The approval, given in September 2017, also applied to those on Incruse Ellipta (umeclidinium) and Breo Ellipta

Data from multiple studies have demonstrated the combination therapy’s benefits to this patient population.

The expanded indication followed a supplemental new drug application supported by data from the Phase 3 IMPACT study (NCT02164513), which compared Trelegy to other common COPD medications: GSK’s once-daily COPD therapies Breo Ellipta (fluticasone furoate/vilanterol) and Anoro Ellipta(umeclidinium/vilanterol). All three treatments were delivered in the same dose and inhaler.

Results from the IMPACT study showed that Trelegy Ellipta significantly reduced the number of COPD exacerbations, and improved the patients’s lung function and quality of life.

“We are pleased that the robust data from the IMPACT study has enabled the expanded indication announced today and the FDA action has been taken so swiftly,” Hal Barron, chief scientific officer and president of R&D, GSK, said in a press release. “We will continue to analyse the data from the IMPACT trial and our ongoing Trelegy Ellipta studies to demonstrate further the value of this important medicine to patients.”

Trelegy Ellipta was approved in the European Union as a maintenance treatment for adults with moderate-to-severe COPD for whom a combination of an inhaled corticosteroid and a long-acting beta2-agonist is insufficient in November.

An application requesting a similar extended indication across the EU was submitted to the European Medicines Agency (EMA) in February and is under review.