The US Food and Drug Administration (FDA) has approved GlaxoSmithKline (GSK) and Theravance's Anoro Ellipta as a once-daily, long-term maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.
Anoro Ellipta, which is a combination of umeclidinium, an inhaled anticholinergic, and vilanterol, a long-acting beta2-adrenergic agonist (LABA), is not indicated for the relief of acute bronchospasm or for the treatment of asthma.
LABA is aimed at improving breathing by relaxing the muscles of the airways to allow more air to flow into and out of the lungs.
The FDA-approved strength is 62.5mcg umeclidinium and 25mcg vilanterol.
The US launch of Anoro Ellipta is expected to commence during the first quarter of 2014.
Under the LABA collaboration deal signed in 2002, Theravance will make a milestone payment of $30m to GSK following FDA approval of Anoro Ellipta and a further $30m payment will also be made to GSK after the US launch of the product.
About 6,000 patients with COPD were assessed in the Phase III program for Anoro Ellipta, which included seven clinical trials.
