New treatment option available January 1 2017 for patients with a form of severe asthma

First therapy approved for severe refractory eosinophilic asthma to be listed on the PBS

A new treatment option for Australian patients with a form of severe asthma is set to become more accessible for eligible patients. GlaxoSmithKline’s (GSK) Mepolizumab (Nucala®) will be reimbursed via the Pharmaceutical Benefits Scheme (PBS) from January 1, 2017, for eligible Australian patients with severe refractory eosinophilic asthma, as an add-on treatment to their existing asthma therapy.

Mepolizumab (Nucala) is the first treatment approved for this specific type of severe asthma. 

More than 2.4 million Australians are affected by asthma1 and it is estimated up to 5-10% have severe asthma2. Nearly 40% of adults with severe asthma are hospitalised at least once a year for the treatment of an asthma flare-up3, while 23% of adolescents and adults with severe asthma have had at least one near-fatal asthma flare-up in their lives4.

Severe eosinophilic asthma is a form of severe asthma, where there are too many eosinophils (a type of white blood cell) in the blood and lungs, which can lead to an increased risk of asthma flare-ups and worsening of asthma symptoms5. It is estimated that 30% of patients with severe asthma in Australia and New Zealand have eosinophilic asthma6.

Mepolizumab is a new add-on treatment option for patients with severe refractory eosinophilic asthma, to help reduce the frequency of their asthma flare-ups, and to reduce the oral steroid dose for those patients taking oral steroids on an ongoing basis5.

Respiratory specialist and Director at Monash Lung and Sleep, Professor Phil Bardin, said he welcomes the availability of a new add-on treatment option on the PBS for eligible patients with severe eosinophilic asthma, who continue to have symptoms and flare-ups, despite being on maximal asthma therapy. 

“Patients with severe refractory eosinophilic asthma do not have typical asthma. It can be a struggle to control their day-to-day symptoms despite maximal doses of prescribed medications. Many patients continue to have frequent asthma flare-ups, which may require hospitalisation, and can have a severe negative impact on their quality of life. It’s a big step forward to be able to offer a treatment specifically developed for this disease type.”

GSK General Manager, Anne Belcher, said the listing was representative of GSK’s ongoing dedication to improving respiratory health in Australia.  

“PBS listing of Nucala in Australia means eligible patients now have access to a new treatment option to help them control their severe asthma symptoms. GSK is committed to developing treatments that can help improve the lives of patients with respiratory illnesses, and making them available and affordable for our Australian patients.”

Important Safety Information for Nucala (Mepolizumab)5

Healthcare professionals, together with their patients, consider both the potential risks (e.g. side effects) and benefits (e.g. effectiveness) of medicines when managing a condition. Information regarding Nucala is available from the Consumer Medicine Information (CMI). A summary of this information is provided below, please review the CMI for further information: http://au.gsk.com/media/351185/nucala_cmi_au_002_approved.pdf

Nucala is a medicine approved for severe eosinophilic asthma. Nucala should not be used for the acute treatment of asthma flare ups. It is intended as an add-on treatment, where patients should continue to take their other asthma medications as prescribed.

Nucala is not recommended for children aged under 12 years or in adolescents who weigh less than 45Kg, as the safety and effectiveness of Nucala are not known in this population.

Do not use Nucala ifthere is an allergy to mepolizumabor any of the other ingredients of this medicine. Allergic or allergic-like eventsoften occur within minutes tohours after Nucala isadministered, but in someinstances symptoms can have adelayed onset of up to severaldays. Symptoms of an allergic reaction can include: swelling of the face, lips, tongue or other parts of the body and rash, itching or hives on the skin.

The benefits and potential risks of being given Nucala during pregnancy and breastfeeding is to be determined by the doctor.

Like all medicines, Nucala can cause side effects, although not everybody gets them. Very common side effects (that may affect more than 1 in 10 people) include: headache. Common side effects (that may affect up to 1 in 10 people) include: injection-site reaction (pain, redness, swelling, itching, and burning sensation of the skin near where the injection was given), back pain, pharyngitis (sore throat), lower respiratory tract infection (congestion, cough, discomfort),nasal congestion (stuffy nose), upper abdominal pain (stomach pain or discomfort in the upper area of the stomach), eczema (itchy red patches on the skin), urinary tract infection (blood in urine, painful and frequent urination, fever, pain in lower back) and fever (high temperature).

Additional notes

The information contained within this media release does not contain all the available information. It does not take the place of talking to your healthcare professional. Please speak to your healthcare professional for further information about severe refractory eosinophilic asthma. 

Professor Phil Bardin has served on advisory boards and been involved in clinical trials sponsored by GSK for which compensation was received. In relation to this GSK media announcement, no compensation was provided to Professor Phil Bardin, and the opinions expressed are his own. Professor Phil Bardin has been briefed by GSK on the approved use of this product.

References:

  1. ABS. National Health Survey: First Results, 2014-15. Canberra: Australian Bureau of Statistics, 2015
  2. Chung KF et al. International ERS/ATS guidelines on definition, evaluation and treatment of severe asthma. European Respiratory Journal of 2014;43:323-373
  3. The ENFUMOSA Study Group. The ENFUMOSA cross-sectional European multicentre study of the clinical phenotype of chronic severe asthma. Eur Respair J. 2003,22:470-477.
  4. Moore WC, et al. Characterization of the severe asthma phenotype by the National Heart, Lung, and Blood Institute’s Severe Asthma Research Program.J Allergy Clin Immunol. 2007; 11:405-413.
  5. Nucala Consumer Medicine Information
  6. Harvey E, et al. Characterisation of severe asthma phenotypes via a severe asthma registry: the severe asthma web-based database. Respirology, 2016;21 (Suppl 2):11

If you are an Australian healthcare professional, please www.health.gsk.com visit for more information on Nucala.  

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

Nucala® is a registered trademark of the GSK group of companies. 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. AUS/NLA/0077/16c. Date of Approval: December 2016

GSK – one of the world’s leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life.  For further information please visit www.au.gsk.com

ENDS

 

This media release has been issued by WE Buchan on behalf of GSK.

GSK Australia Enquiries or interview requests contact:

Kim O’Donohue
0477 322 431
kim.j.odonohue@gsk.com 

               
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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.