FDA approves Anoro Ellipta for COPD-GSK/Theravance
GlaxoSmithKline plc and Theravance, Inc. have announced that the FDA has on 18 December 2013, approved Anoro Ellipta a combination anticholinergic/long-acting beta2-adrenergic agonist (LABA) indicated for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with Chronic Obstructive Pulmonary Disease (COPD), including chronic bronchitis and/or emphysema.
Anoro Ellipta is not indicated for the relief of acute bronchospasm or for the treatment of asthma. Anoro Ellipta (umeclidinium and vilanterol inhalation powder) is the first once-daily product approved in the US that combines two long-acting bronchodilators in a single inhaler for the maintenance treatment of COPD. The FDA-approved strength is umeclidinium/vilanterol 62.5 mcg/25 mcg.
Following this approval by the FDA, it is anticipated that launch activities in the US will commence during the first quarter of 2014.
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