GSK announces regulatory submission for umeclidinium monotherapy in US

Issued: London UK – LSE Announcement

GlaxoSmithKline plc (LSE:GSK) today announced the submission of a regulatory application in the US for the investigational once-daily medicine, umeclidinium bromide (UMEC), for patients with chronic obstructive pulmonary disease (COPD). On 26^th April, GSK announced the submission of a regulatory application in Europe for UMEC for patients with COPD.

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

A New Drug Application (NDA) for UMEC monotherapy (62.5mcg) has been submitted to the US Food and Drug Administration (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 (contained inside the inhaler) which is equivalent to the 55mcg delivered dose (emitted from the inhaler) submitted for approval in Europe.

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

Other Respiratory Development Programmes: 
UMEC monotherapy is one of several late-stage assets in the GSK respiratory development portfolio. The development portfolio includes umeclidinium /vilanterol (UMEC/VI, with proposed brand name ANORO™), fluticasone furoate/vilanterol (FF/VI, with proposed brand names RELVAR™ and BREO™), VI monotherapy and MABA (GSK961081), developed in collaboration with Theravance, as well as GSK’s investigational medicines FF monotherapy and anti-IL5 MAb (mepolizumab). These investigational medicines are not currently approved anywhere in the world.

ANORO™, RELVAR™, BREO™ and ELLIPTA™ are trademarks of the GlaxoSmithKline group of companies.  The use of these brand names is not approved by any regulatory authorities.

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