NDA Submitted for Combination COPD Drug
GlaxoSmithKline and Theravance announced the submission of a New Drug Application (NDA) for the investigational once-daily LAMA/LABA combination medicine, UMEC/VI, for patients with chronic obstructive pulmonary disease (COPD). UMEC/VI includes two bronchodilator molecules - GSK573719 or umeclidinium bromide (UMEC), a long-acting muscarinic antagonist (LAMA) and vilanterol (VI), a long-acting beta2 agonist (LABA), administered using the Ellipta inhaler.
The NDA submitted for UMEC/VI (62.5/25mcg and 125/25mcg doses) includes the proposed proprietary name Anoro Ellipta. GlaxoSmithKline and Theravance are seeking the drug's approval for the long-term once-daily maintenance bronchodilator treatment of airflow obstruction in patients with COPD, including chronic bronchitis and emphysema.