GSK announces regulatory submission for umeclidinium monotherapy for COPD in Japan
GlaxoSmithKline plc (LSE: GSK) today announced the submission of a regulatory application to the Japanese Ministry of Health, Labour and Welfare (MHLW) for umeclidinium (UMEC), a long-acting muscarinic antagonist (LAMA), administered using the Ellipta™ dry powder inhaler.
The New Drug Application has been submitted to the MHLW for UMEC monotherapy (62.5mcg), as a once-daily inhaled dry powder maintenance bronchodilator treatment to relieve symptoms in adult patients with Chronic Obstructive Pulmonary Disease (COPD).
UMEC has recently been granted market authorisation in the US, Canada and in Europe, with the approved trade name Incruse™ Ellipta™. Regulatory filings in other countries will take place throughout 2014 and onwards.
UMEC is not currently approved in Japan and is not licensed anywhere outside of the US, Canada and the European Union.
INCRUSE™ and ELLIPTA™ are trademarks of the GlaxoSmithKline group of companies.
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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. Such factors include, but are not limited to, those described under Item 3.D 'Risk factors' in the company's Annual Report on Form 20-F for 2013.