Incruse® Ellipta® (umeclidinium) approved in Australia for Chronic Obstructive Pulmonary Disease

GlaxoSmithKline has announced today that the Therapeutic Goods Administration (TGA) has approved Incruse® Ellipta® (umeclidinium), a maintenance treatment to relieve symptoms in Australian adult patients with chronic obstructive pulmonary disease (COPD), also known as “chronic bronchitis,” “smoker’s cough” or “emphysema”.

  • Administered using a new dry powder inhaler called Ellipta1

GlaxoSmithKline has announced today that the Therapeutic Goods Administration (TGA) has approved Incruse® Ellipta® (umeclidinium), a maintenance treatment to relieve symptoms in Australian adult patients with chronic obstructive pulmonary disease (COPD), also known as “chronic bronchitis,” “smoker’s cough” or “emphysema”.

Incruse Ellipta is a bronchodilator (medicine that helps make breathing easier) and consists of a long-acting muscarinic antagonist (LAMA) known as umeclidinium.

GSK Associate Medical Director, Dr Navin Singh says the approval is another crucial step forward in the development of GSK’s respiratory portfolio in Australia.

“We are delighted by the TGA approval of Incruse Ellipta, our first LAMA, which will provide healthcare professionals with a further treatment option for appropriate COPD patients. GSK continues to be committed to developing a range of new therapeutic options that will enable physicians to make treatment choices based on individual patient needs,” said Dr Singh.

For a copy of the Consumer Medicine Information, please visit: http://www.gsk.com.au/incruse

About COPD
COPD is a term for a group of respiratory disorders including emphysema and chronic bronchitis3. The prevalence of self-reported emphysema/bronchitis in COPD effects approx 5% of Australians over 552.

About Incruse Ellipta1
Incruse Ellipta is a long-acting muscarinic antagonist (LAMA), which is a type of bronchodilator also known as an anticholinergic. Incruse Ellipta is a 62.5mcg strength inhalation powder delivered by the Ellipta® inhaler and is a maintenance bronchodilator treatment to relieve symptoms in adult patients with COPD.

Following TGA registration GSK’s next focus is to make Incruse Ellipta available to prescribers. Incruse Ellipta is not available on the Pharmaceutical Benefits Scheme (PBS).

Healthcare professionals together with their patients consider both the potential risks (eg. side effects) and benefits (eg. effectiveness) of medicines when managing a condition. Information regarding Incruse Ellipta is available from the Consumer Medicine Information (CMI). A summary of this information is provided below, please review the CMI for further information1.

Incruse Ellipta should not be used to relieve a sudden attack of breathlessness or wheezing. Incruse Ellipta should not be used in patients with an intolerance to lactose or allergy to milk or any of the other ingredients within the medicine1.

Incruse Ellipta needs to be used with care in specific patients, including those with heart or blood pressure problems, eye problems (specifically, narrow-angle glaucoma), enlarged prostate gland or difficulty passing urine or with a blockage in the bladder1.

For a copy of the Consumer Medicine Information, please ask your healthcare professional or visit http://www.gsk.com.au/incruse

References:
1. Incruse® Ellipta® Consumer Medicine Information July 2014
2. National Health survey 2007-8; adults. Prevalence in adults stable (AIHW: 2011; COPD in Australia p14; p164).
3. Lung Foundation Australia website: http://lungfoundation.com.au/patient-area/lung-diseases/copd/

For full product information, information on GSK products or to report an adverse event involving a GSK product, please contact GSK Medical Information on 1800 033 109. GlaxoSmithKline Australia Pty Ltd. ABN 47 100 162 481. Melbourne, VIC.

Incruse® and Ellipta® are trade marks of the GSK group of companies.

GSK – 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

You can follow GSK on Twitter for more Australian updates @GSK_AU.

This media release has been issued by Palin Communications on behalf of GSK.


GSK Australia Enquiries or interview requests contact:


Martin Palin
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martin@palin.com.au

Ishtar Schneider
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