GlaxoSmithKline plc (LSE/NYSE: GSK) and Theravance, Inc. (NASDAQ: THRX) today announced that Anoro™ Ellipta® (umeclidinium and vilanterol inhalation powder), the first once-daily product approved in the US that combines two long-acting bronchodilators in a single inhaler for the maintenance treatment of chronic obstructive pulmonary disease (COPD), is now available to retail pharmacies in the US.
Anoro Ellipta is a combination anticholinergic/long-acting beta2-adrenergic agonist (anticholinergic/LABA) indicated for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with COPD, including chronic bronchitis and/or emphysema. Anoro Ellipta is not indicated for the relief of acute bronchospasm or for the treatment of asthma. The FDA-approved strength is umeclidinium/vilanterol 62.5/25mcg.
"We understand that COPD is a progressive disease affecting an estimated 27 million people in the US alone," said Jorge Bartolome, Senior Vice President of the GSK Respiratory Business Unit in the US. "Anoro Ellipta is an important treatment option for appropriate patients with COPD, and we are proud to make it available in the US."
"We are very pleased that Anoro Ellipta, the latest combination medicine to be developed as a result of our partnership with GSK, is now available in the US," said Rick E Winningham, Chief Executive Officer of Theravance. "We believe this product will add to the choice of treatment options available to healthcare physicians when considering how to help meet the needs of their patients."
Under the terms of its 2002 LABA collaboration agreement with GSK, Theravance agreed to make a milestone payment of $30 million (USD) to GSK following the launch of Anoro Ellipta in the US.
The FDA approved Anoro Ellipta on December 18, 2013.