FDA Approves GSK's Anoro Ellipta for COPD Treatment in US
The US Food and Drug Administration (FDA) has approved GlaxoSmithKline plc's (GSK) Anoro Ellipta. It is the first once-daily dual bronchodilator for the maintenance treatment of chronic obstructive pulmonary disease (COPD) in the United States.
The US Food and Drug Administration (FDA) has approved Anoro Ellipta, developed by GlaxoSmithKline plc (GSK) and Theravance, Inc., for the long-term, once-daily maintenance treatment of chronic obstructive pulmonary disease (COPD). The medication combines two long-acting bronchodilators, umeclidinium and vilanterol, in a single inhaler.
The approval is for the 62.5 mcg umeclidinium/25 mcg vilanterol strength. Anoro Ellipta is not indicated for the relief of acute bronchospasm or for the treatment of asthma. The launch in the US is anticipated to commence in the first quarter of 2014.
Anoro Ellipta marks the first once-daily combination product approved in the US for COPD maintenance therapy. The development program included seven Phase III clinical studies involving nearly 6,000 COPD patients.
COPD is a lung disease characterized by airflow obstruction that interferes with normal breathing. An estimated 27 million people in the US are affected by COPD, often caused by long-term exposure to lung irritants such as cigarette smoke.