UK-based GlaxoSmithKline (GSK) and US-based Theravance have announced the availability of BREO ELLIPTA, a once-daily prescription medicine for chronic obstructive pulmonary disease (COPD), in the US pharmacies.
BREO ELLIPTA is a combination of fluticasone furoate 'FF' and vilanterol 'VI' (FF/VI 100/25mcg) indicated for the treatment of airflow obstruction in patients with COPD, including chronic bronchitis and/or emphysema.
Fluticasone furoate is an inhaled corticosteroid and vilanterol is a long-acting beta2-agonist (LABA).
The medicine is also indicated for reducing exacerbations of COPD in patients with a history of exacerbations, and is not indicated for the relief of acute bronchospasm or for the treatment of asthma.
GSK US respiratory business unit senior vice president Jorge Bartolome noted patients and physicians have a new treatment option with BREO ELLIPTA, the first once-daily ICS/LABA for the maintenance treatment of COPD.
"This new option for healthcare providers to prescribe is good news for the millions of people in the U.S. affected by COPD," Bartolome added.
Theravance CEO Rick E Winningham noted launching BREO ELLIPTA and making this important new medicine available to COPD patients is a significant milestone, which has been built upon many years of research and development.
"We, like GSK, are proud to make the option of treatment with BREO ELLIPTA a reality for appropriate patients in the US," Winningham added.
Pursuant to the terms of the 2002 LABA collaboration agreement between Theravance and GSK, Theravance will make a milestone payment of $30m to GSK following the launch of BREO ELLIPTA in the US.
BREO ELLIPTA has obtained the US Food and Drug Administration approval in May 2013.
In July 2013, Health Canada has approved FF/VI 100/25mcg under the trade name BREO ELLIPTA.
In September 2013, the Japanese Ministry of Health, Labour and Welfare has approved FF/VI 100/25mcg and 200/25mcg under the trade name RELVAR ELLIPTA for the treatment of bronchial asthma.
