The US Food and Drug Administration (FDA) has approved an expanded indication for GlaxoSmithKline's single inhaler triple therapy Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol) to include a broader population of chronic obstructive pulmonary disease (COPD) patients with airflow limitation or who have experienced an acute worsening of respiratory symptoms.
"The new indication is for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with COPD, including chronic bronchitis and/or emphysema. It is also indicated to reduce exacerbations of COPD in patients with a history of exacerbations. It is not indicated for relief of acute bronchospasm or for the treatment of asthma," the company said in a news release.
The FDA first approved Trelegy Ellipta in September 2017 for the long-term, once-daily maintenance treatment of COPD patients who are receiving Breo Ellipta (fluticasone furoate/vilanterol) and require additional bronchodilation or who are receiving Breo Ellipta and Incruse Ellipta (umeclidinium).
Approval for the expanded indication is based on data from Informing the Pathway of COPD Treatment (IMPACT) study involving more than 10,000 patients. The study found that Trelegy Ellipta was superior to Breo Ellipta and Anoro Ellipta (umeclidinium/vilanterol) on multiple clinically important endpoints, including reducing exacerbations and improving lung function and health-related quality of life, the company said.
"Up to half of patients with COPD on maintenance therapy will have experienced at least one exacerbation in the past 12 months, so gaining an indication that reflects the role Trelegy Ellipta can play in reducing this risk is important," Ted Witek, DrPH, chief scientific officer at Innoviva, said in the release. "We welcome this regulatory update which will allow physicians to offer the benefits of once-daily single inhaler triple therapy to appropriate patients with COPD."
Full prescribing information for Trelegy Ellipta is available online.
Cite this: FDA Expands Indication for Trelegy Ellipta in COPD - Medscape - Apr 24, 2018.