New medicine for lupus now available in Australia

GSK is pleased to announce that BENLYSTA® (belimumab) is now available in Australia for use as an add-on therapy in adult patients with active, autoantibody-positive systemic lupus erythematosus (SLE) with a high degree of disease activity despite standard therapy. 1

GSK is pleased to announce that BENLYSTA® (belimumab) is now available in Australia for use as an add-on therapy in adult patients with active, autoantibody-positive systemic lupus erythematosus (SLE) with a high degree of disease activity despite standard therapy.1

Lupus is a serious, chronic and debilitating disease of the immune system that usually affects people in their prime between the ages of 15 and 44; 90% of those affected are women.2,3 It is estimated up to 32,000 people in Australia are living with various forms of lupus, including SLE.4 The current goal of treatment is to control disease activity and minimise complications.5,6 Persistent disease activity has been shown to contribute to organ damage and mortality.5,6 Many patients remain uncontrolled on standard therapy, including suffering unpredictable flares of disease activity or experiencing unacceptable side effects.5

According to Professor Eric Morand, the Head of Rheumatology at Monash Health and the Centre for Inflammatory Diseases at Monash University, the registration of a new option for the treatment in Australia represents a major development in the management of lupus for affected Australians.

“There are significant clinical challenges associated with the treatment of lupus. A new treatment option will be welcomed by many physicians frustrated by a lack of progress in the management of this disease,” said Professor Morand.

BENLYSTA is a monoclonal antibody that inhibits soluble BlyS. BlyS is believed to be important in the production of antibodies which attack and destroy the body’s own healthy tissues.1 BENLYSTA, a hospital administered infusion treatment, represents an important new therapeutic option which specifically targets one of the underlying abnormalities seen in SLE.1

BENLYSTA’s approval was based on two clinical trials, known as BLISS-52 and BLISS-76, comprising one of the largest clinical trial programmes ever conducted in lupus patients and involving nearly 1700 patients from over 30 countries.7,8,9 This programme defined the SLE patient type suitable for BENLYSTA and forms the basis of its approval by the TGA in Australia.

“Benlysta is the first new treatment approved for lupus in decades. GSK is proud to bring a new treatment to the lupus community to help people living with severe forms of the disease” said GSK Associate Medical Director, Specialty Medicine, David Crump.

BENLYSTA has not been studied in patients with lupus involving the nervous system or kidney, in patients with HIV, hepatitis B or C, or in patients with a history of organ or cell transplantation. BENLYSTA is not recommended for use in children and adolescents under 18 years, or in patients who are pregnant or suffering from severe kidney impairment. Care should be taken if BENLYSTA is used in patients who have had allergic reactions to other medicines or infusion reactions, who have infections, require immunisation with live vaccines, have cancer, or suffer from depression. Like other medicines, BENLYSTA can cause some side effects, although most are minor and temporary1. Common side effects associated with treatment on BENLYSTA include reactions to the infusion, allergic reactions, infections, fever, headache, joint pain, nausea, diarrhoea and fatigue.

BENLYSTA is not available on the Pharmaceutical Benefit Scheme (PBS). BENLYSTA is available through private prescription and through several hospitals in Australia.

In the management of diseases, healthcare professionals in consultation with their patients should consider both the potential risks (eg. side effects) and benefits (eg. effectiveness) of each medicine. Information is available from the Consumer Medicine Information (CMI) and Product Information.

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 healthcare professionals. Please speak to your health care professional for further information about lupus or Benlysta. For a copy of the Consumer Medicine Information, please ask your healthcare professional or visit: www.gsk.com.au.

-ENDS-

MEDIA CONTACTS:
For further information please call Martin Palin (0418 419 258 / martin@palin.com.au) or Ishtar Schneider (0422 944 023 / ishtar@palin.com.au) at Palin Communications on 02 9412 2255.

Disclosures
Professor Morand has been involved in clinical trials sponsored by GSK and has received honoraria for speaker and chair duties at GSK developed educational meetings. In relation to this GSK media announcement, no compensation was provided to Professor Morand and the opinions expressed are his own. Professor Morand has been briefed by GSK on the approved use of this product.

For full consumer medicines information, please visit: http://www.gsk.com.au/benlysta

GlaxoSmithKline Australia Pty Ltd. Melbourne, VIC. ABN 47 100 162 481. For 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 Victoria. www.gsk.com.au. Benlysta is a registered trade mark of the GSK group of companies. AUS/BEL/0003/14. Date of approval July 2014.

References:
1. Benlysta Approved Product Information, please see latest version on www.gsk.com.au/benlysta
2. Lupus Foundation of America. Statistics on Lupus. http://www.lupus.org/about/statistics-on-lupus Accessed on 13 June, 2014.
3. NHS Choices - www.nhs.uk/conditions/lupus/pages/introduction.aspx, Accessed on 13 June, 2014.
4. http://www.arthritisvic.org.au/Useful-Information/About-Us/Publications/Lupus-report.aspx. Accessed on 20 June, 2014.
5. Kalunian, K, Merrill, JT. Curr Med Res Opin 2009; 25:1501-1514.
6. Berker-Merok, A, Nossent H. J Rheumatol 2006; 33: 1570-1577.
7. Navarra, S et al. Lancet, 2011; 377 (9767):721-731.
8. Furie, R etal. Arthritis and Rheumatism, 2011; 63(12):3918–3930
9. Van Vollenhoven RF et al. Ann Rheum Dis 2012; 71:1343–1349.