GSK announces regulatory submission for umeclidinium monotherapy in European Union

New Drug Approvals

 

Umeclidinium bromide

http://www.ama-assn.org/resources/doc/usan/umeclidinium-bromide.pdf

26 April 2013
GlaxoSmithKline plc  today announced the submission of a regulatory application in the European Union for the investigational once-daily medicine, umeclidinium bromide (UMEC), for patients with chronic obstructive pulmonary disease (COPD).

UMEC is an investigational bronchodilator molecule (formerly known as GSK573719), a long-acting muscarinic antagonist (LAMA), administered using the ELLIPTA™ inhaler.

A Marketing Authorisation Application (MAA) for UMEC monotherapy (55 mcg delivered dose) has been submitted to the European Medicines Agency (EMA), for a maintenance bronchodilator treatment to relieve symptoms in adult patients with COPD.

Regulatory filings for UMEC monotherapy are imminent in the US and planned in other countries during the course of 2013.

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