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news.GlaxoSmithKline (GSK) has submitted a new drug application (NDA) to the US FDA for umeclidinium bromide (UMEC) monotherapy 62.5mcg to treat chronic obstructive pulmonary disease (COPD).
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The investigational once-daily UMEC, administered using the Ellipta inhaler, is a bronchodilator molecule and a long-acting muscarinic antagonist (LAMA).
Application is submitted for the maintenance bronchodilator treatment of airflow obstruction in COPD patients, including chronic bronchitis and emphysema.
The company earlier submitted a regulatory application for UMEC in Europe for patients with COPD while regulatory filings in countries are planned during the course of 2013.
The 62.5mcg UMEC dose is specified as the pre-dispensed dose (contained inside the inhaler) which is equivalent to the 55mcg delivered dose (emitted from the inhaler) submitted for approval in Europe, according to the company.