GlaxoSmithKline plc (GSK,GSK.L) announced the submission of a regulatory application in the US for the investigational once-daily medicine, umeclidinium bromide or UMEC, for patients with chronic obstructive pulmonary disease or COPD. On April 26th, GSK announced the submission of a regulatory application in Europe for UMEC for patients with COPD.
UMEC is an investigational bronchodilator molecule, earlier known as GSK573719, a long-acting muscarinic antagonist or LAMA, administered using the ELLIPTA inhaler.
A New Drug Application or NDA for UMEC monotherapy (62.5mcg) has been submitted to the FDA, for the long-term once-daily maintenance bronchodilator treatment of airflow obstruction in patients with COPD, including chronic bronchitis and emphysema. The UMEC dose of 62.5mcg is specified as the pre-dispensed dose, which is equivalent to the 55mcg delivered dose submitted for approval in Europe.
Regulatory filings for UMEC monotherapy are planned in other countries in the course of 2013.
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