Issued: Tuesday 30 April 2013, London UK - LSE Announcement
GSK announces regulatory submission for umeclidinium monotherapy in US
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 26th 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.
V A Whyte
Company Secretary
30 April 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.
GlaxoSmithKline - one of the world's leading research-based pharmaceutical and healthcare companies - is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For further information please visit www.gsk.com
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Cautionary statement regarding forward-looking statements
GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Factors that may affect GSK' s operations are described under Item 3.D 'Risk factors' in the company's Annual Report on Form 20-F for 2012. |
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