Theravance and GlaxoSmithKline announced the launch of Anoro Ellipta (umeclidinium and vilanterol inhalation powder) in the U.S. as maintenance treatment of chronic obstructive pulmonary disease (COPD). Anoro Ellipta, now available in retail pharmacies across the country, is the first once-daily product combining two long-acting bronchodilators in a single inhaler approved by the FDA.
The product combines anticholinergic/long-acting beta2-adrenergic agonist (anticholinergic/LABA) indicated for long-term, once-daily, maintenance treatment of airflow obstruction in patients with COPD, including chronic bronchitis and/or emphysema. The drug is not indicated for the relief of acute bronchospasm or for the treatment of asthma. FDA-approved strength of the drug is umeclidinium/vilanterol 62.5/25mcg. The FDA approved Anoro Ellipta in December of 2013.
Chronic obstructive pulmonary disease (COPD) includes chronic bronchitis and emphysema within its diagnosis. The World Health Organization (WHO) describes COPD as not simply a smoker’s cough but as an under-diagnosed, life threatening lung disease that may progressively lead to death. The disease is projected to become the third leading cause of death worldwide by 2030.
Jorge Bartolome, SVP of the GSK Respiratory Business Unit in the U.S., said, “We understand that COPD is a progressive disease affecting an estimated 27 million people in the US alone. Anoro Ellipta is an important treatment option for appropriate patients with COPD, and we are proud to make it available in the U.S..”
Rick Winningham, CEO of Theravance, said, “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. 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 the 2002 LABA collaboration agreement, Theravance will pay a milestone payment of $30 million to GSK following the launch of Anoro Ellipta in the U.S.