Significant Advancement In Chronic Kidney Disease (CKD) Treatment With TGA Approval Of Forxiga (Dapagliflozin)

Forxiga® (dapagliflozin) now TGA registered for use in Australia

  • Approximately 1.7 million adult Australians (1 in 10) have indicators of chronic kidney disease3, with approximately 90% of people with the condition going undetected4
  • Chronic kidney disease costs the Australian health system an estimated $5.1 billion per year3
  • Forxiga® (dapagliflozin) is now approved to reduce the risk of progressive decline in kidney function in adults with proteinuric chronic kidney disease2, which represents the first new treatment for the chronic condition in 20 years1

Friday 24 September 2021, Sydney: AstraZeneca is pleased to announce that the Therapeutic Goods Administration (TGA) has approved the use of oral therapy Forxiga® (dapagliflozin) in Australia, to reduce the risk of progressive decline in kidney function in adults with proteinuric chronic kidney disease (CKD Stage 2, 3 or 4 and urine ACR ≥ 30 mg/g).2

This represents the first treatment to slow the progression of chronic kidney disease in 20 years.1

Kidney Health Australia - the peak body for kidney health in Australia - welcomed the news today.

“Due to the silent nature of the condition, people may be at risk of losing up to 90% of their kidney function before visible symptoms appear.3 We need to be driving greater awareness of this major public health issue so we are better at educating, diagnosing and treating those affected. Emerging treatments for chronic kidney disease are so important, as they give Australians living with the disease the opportunity to more effectively manage their condition,” said Chris Forbes, CEO of Kidney Health Australia.

Chronic kidney disease, a condition where there is a loss of kidney function over time5. It is a chronic condition that rarely occurs in isolation and is often associated with high blood pressure (hypertension), type 2 diabetes, heart failure and other conditions.3 An estimated 29% of Australian adults have one or more of these conditions, and approximately one quarter have at least two of these conditions4.

According to Dr Kean-Seng Lim - general practitioner (GP) - people should talk to their GP if they have key risk factors for chronic kidney disease.

“We know chronic kidney disease tends to go undetected and is often identified in its later stages. In our practice we have many adult patients who are at high risk of chronic kidney disease. This includes patients who have other conditions that we monitor, such as type 2 diabetes, hypertension and cardiovascular disease. The best opportunities to screen for chronic kidney disease is during regular GP visits, because they know you best. Having new treatment options for this disease will help doctors intervene earlier,” said Dr Lim. 

Liz Chatwin - Country President at AstraZeneca Australia and New Zealand - said the new indication for Forxiga® was an important step toward transforming treatment for chronic kidney disease.

“For more than 60 years AstraZeneca has been committed to improving the lives of Australians living with chronic conditions. This approval has the potential to transform treatment of people living with chronic kidney disease. We hope that the news of this indication will also drive important discussions about improved detection and help build better awareness of chronic kidney disease,” said Ms Chatwin.

Forxiga® contains the active ingredient dapagliflozin.2

All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects. Ask your doctor or pharmacist to answer any questions you may have. Side effects of FORXIGA include6:

  • hypoglycaemia
  • genital infections as suggested by irritation of the genitals
  • urinary tract infections
  • back pain
  • changes in the amount of cholesterol or fats in your blood 
  • headache.

For additional information; refer to the Forxiga CMI and/or speak to your HCP. 

For further information regarding chronic kidney disease, please speak with a health care professional or visit the Kidney Health Australia website: https://kidney.org.au/.

For a copy of the Consumer Medicine Information (CMI) for Forxiga® please ask your healthcare professional or view online – www.astrazeneca.com.au/CMI.

PBS Information: FORXIGA:

PBS Information: FORXIGA: Type 2 Diabetes: Authority Required (STREAMLINED). Refer to PBS Schedule for full Authority Required Information. Chronic Kidney Disease and Heart Failure: Not listed on the PBS.

This media release has been distributed by Palin Communications on behalf of AstraZeneca Australia.

Dr Lim has served on advisory boards sponsored by AstraZeneca for which compensation was received. In relation to this AstraZeneca media announcement, no compensation was provided to Dr Lim, and the opinions expressed are his own. Dr Lim has been briefed by AstraZeneca on the approved use of this product.

AstraZeneca proudly supports Kidney Health Australia through sponsorship of health care professional education, disease awareness, patient education and activities supporting patients with chronic kidney disease.

About chronic kidney disease

For more information about chronic kidney disease please visit the Kidney Health Australia website at, https://kidney.org.au/

For over 50 years Kidney Health Australia has been the peak body for kidney health, connecting people to the vital information, education, and support services they need to preserve their kidney health and live a better quality of life if they are diagnosed with kidney disease. The organisation works with the clinical and research community to support treatment and research improvements and innovations to foster a future without kidney disease.

About Forxiga®6

Forxiga® is indicated to reduce the risk of progressive decline in kidney function in adults with proteinuric chronic kidney disease (CKD Stage 2, 3 or 4 and urine ACR ≥ 30 mg/g).

Forxiga® is a prescription medicine used with diet, exercise and sometimes other medicines to control the levels of blood sugar (glucose) in adults with type 2 diabetes mellitus. It can also reduce hospitalisation for heart failure in adults with type 2 diabetes. Forxiga® is also used with other medicines to treat heart failure and to slow the progression of kidney disease in adults.

About AstraZeneca

AstraZeneca (LSE/STO/NYSE: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three therapy areas – Oncology; Cardiovascular, Renal & Metabolism; and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide.

For more information, please visit www.astrazeneca.com and www.astrazeneca.com.au

AstraZeneca Pty. Ltd. ABN 54 009 682 311. 66 Talavera Road, Macquarie Park, NSW 2113. www.astrazeneca.com.au. For Medical Information enquiries: 1800 805 342 or medinfo.australia@astrazeneca.com. To report an adverse event: 1800 805 342 or via https://aereporting.astrazeneca.com

References

  1. Breyer MD, Susztak K. Nat Rev Drug Discov. 2016 Aug;15(8):568-88. doi: 10.1038/nrd.2016.67
  2. Forxiga® product information. Available at www.astrazeneca.com.au/PI 
  3. Kidney Health Australia, Chronic Kidney Disease (CKD) Management in Primary Care: Guidance and clinical tips to help detect, manage and refer patients in your practice with CKD, 4th ed. 2020. Available at: https://kidney.org.au/health-professionals/ckd-management-handbook 
  4. Kidney Health Australia, Make the link: Kidney, diabetes and heart evidence report 2021. Available at https://kidney.org.au/get-involved/advocacy/make-the-link-kidneys-diabetes-and-heart (accessed June 2021)  
  5. Kidney Health Australia, What is Kidney Disease? Available at: https://kidney.org.au/your-kidneys/what-is-kidney-disease  
  6. Forxiga® consumer medicines information. Available at www.astrazeneca.com.au/CMI

AU-11435. Prepared September 2021