Breo Ellipta is our second asthma treatment to be approved in the US in the past year, and now provides physicians with a range of treatment options delivered via the Ellipta inhaler to meet the needs of appropriate adult patients with differing asthma severities.
said: "We believe the approval of Breo Ellipta as a once-daily ICS/LABA treatment for adults with asthma is a significant catalyst for Theravance, as asthma affects nearly 19 million adults in the US.
Both Breo Ellipta and vilanterol, a long-acting beta2-adrenergic agonist (LABA), is crucial for Theravance.
Breo Ellipta, a blend of fluticasone furoate, is an inhaled corticosteroid.
is a combination of the inhaled corticosteroid (ICS), fluticasone furoate FF , and the long-acting beta2 agonist (LABA), vilanterol VI (FF/VI 100/25 mcg).
, is the proposed proprietary name for FF/VI 100/25 mcg, a combination of the inhaled corticosteroid (ICS) fluticasone furoate FF and the long acting bronchodilator (LABA) vilanterol VI (FF/VI).
is also indicated to reduce exacerbations of COPD in patients with a history of exacerbations.
is expected to be available from the third/fourth quarter of 2013.
Rick E Winningham, Theravance's Chief Executive Officer, said, "In the second half of 2013, we anticipate a number of significant events: the launch of BREO ELLIPTA
in the U.
We note that Glaxo's product portfolio was boosted recently with the approvals of two melanoma drugs, Tafinlar (dabrafenib) and Mekinist (trametinib) and chronic obstructive pulmonary disease drug, Breo Ellipta
Darrell Baker, SVP & Head, GSK Global Respiratory Franchise, said, "This approval means that we can now realise our plan to bring BREO ELLIPTA
to appropriate COPD patients in the US.
The panel's positive recommendation of BREO ELLIPTA
represents an important achievement in a transformative year for Theravance.