GlaxoSmithKline‘s Breo Ellipta for the treatment of chronic obstructive pulmonary disease (COPD) has been approved by the US Food and Drug Administration.
The FDA licensed the once-daily drug for the treatment of airflow obstruction in patients with COPD, including chronic bronchitis and / or emphysema.
The agency said the therapy is also approved to reduce exacerbations of COPD in patients with a history of exacerbations.
Breo Ellipta combines GlaxoSmithKline’s fluticasone furoate, which the company markets as Avamys / Veramyst, with vilanterol inhalation powder.
The drug was developed in conjunction with San Francisco-based Theravance, in which Glaxo has a 27% shareholding.
GSK Global Respiratory Franchise head Darrel Barker said the approval is an important milestone for the partnership, after more than a decade of joint respiratory research and development.
"This approval means that we can now realise our plan to bring Breo Ellipta to appropriate COPD patients in the US. We know that one of the main issues for patients who have experienced a COPD exacerbation is concern about possible future episodes. Breo Ellipta will help patients breathe better day-to-day and reduce the risk of future exacerbations, with a once-daily inhalation," said Barker.
COPD, the third leading cause of death in the US, is a serious lung disease that worsens over time. Symptoms can include chest tightness, chronic cough and excessive phlegm.
The safety and efficacy of Breo Ellipta were evaluated in 7,700 patients with a clinical diagnosis of COPD. Those treated showed improved lung function and reduced exacerbations compared to placebo.
The drug should not be used as a rescue therapy to treat sudden breathing and is not recommended for people younger than 18 years, the FDA said.
Image: COPD is the third leading cause of death in the US. Photo: Courtesy of FreeDigitalPhotos.net.