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December 19, 2013

GSK and Theravance secure FDA approval for COPD drug Anoro Ellipta

GlaxoSmithKline (GSK) and Theravance have received approval from the US Food and Drug Administration (FDA) for their Anoro Ellipta as a once-daily, long-term maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD).

GlaxoSmithKline (GSK) and Theravance have received approval from the US Food and Drug Administration (FDA) for their Anoro Ellipta as a once-daily, long-term maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD).

Anoro Ellipta is also indicated for the treatment of chronic bronchitis and/or emphysema, and not for the relief of acute bronchospasm or for the treatment of asthma.

It is a combination of umeclidinium, an inhaled anticholinergic that affects the muscles around the large airways and stops the muscles from tightening, and vilanterol, a long-acting beta2-adrenergic agonist (LABA).

LABA helps in improving breathing by relaxing the muscles of the airways to allow more air to flow into and out of the lungs.

"It is the first combination product approved in the US that delivers two once-daily bronchodilators in a single inhaler."

The FDA-approved strength is 62.5mcg umeclidinium, an anticholinergic, and 25mcg vilanterol, a LABA.

GSK Global Respiratory Franchise SVP and head Darrell Baker said the company believes Anoro Ellipta will be a major treatment option for appropriate patients with COPD.

"It is the first combination product approved in the US that delivers two once-daily bronchodilators in a single inhaler," Baker said.

According to the companies, the US launch of Anoro Ellipta is expected to commence during the first quarter of 2014.

As part of the LABA collaboration deal signed by both the companies in 2002, Theravance will make a milestone payment of $30m to GSK following FDA approval of Anoro Ellipta and a further $30m payment will be made to GSK after the US launch of the product.

Around 6,000 patients with COPD were evaluated in the Phase III programme for Anoro Ellipta, which included seven clinical trials.

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