Australian led global research leads to TGA approval for the treatment of lupus

The Therapeutic Goods Administration (TGA) has announced the approval of a drug that offers breakthrough new hope for the treatment of lupus, a disease that affects 1 in 1,000 Australians, mostly women between the ages of 15 and 45 and for which, to date, there has been little treatment and no cure. 

In 2020, the prestigious New England Journal of Medicine published the results of an international, three-year, Phase 3 trial of a drug to treat the autoimmune disease known as systemic lupus erythematosus (SLE, or lupus).  

Professor Eric Morand, Head of the School of Clinical Sciences, Monash University, led this global trial of AstraZeneca’s anifrolumab for lupus treatment, which was approved last year by the United States Food and Drug Administration to be used in the US. Earlier this year, similar approval was granted by the European Medicines Association. 

The TGA approval for anifrolumab now means that anifrolumab is approved for treating lupus patients in Australia based on its effectiveness and safety. This approval is a vital step in widely available medicine for Australian lupus patients. The next step is approval by the Pharmaceutical Benefits Scheme (PBS) to enable the cost of anifrolumab to be subsidised by the federal government.  

Lupus is an autoimmune disease in which the immune system attacks multiple parts of the body. It is particularly prevalent in Indigenous Australian, Asian and other non-European people, with a ten-year mortality of 10%, “which if you are diagnosed in your early twenties is a terrible outcome,” according to Professor Morand.  

Professor Morand, Director of Rheumatology at Monash Health, said that the approval of the drug in the US, Europe and now Australia “is what every clinician dreams of, to take a new treatment through clinical trials and see it become available to help patients.” 

According to Professor Morand, there has only been one new treatment approved for the disease in Australia in the last 60 years, which is not available on the PBS. “This lack of breakthroughs is especially frustrating for the mostly young women affected by lupus, which can have a devastating effect on people in the prime of life.” 

Between 60% and 80% of adults with SLE show signs of overproduction of the immune protein ‘Type 1 interferon’. While previous attempts to block this protein in lupus have failed, anifrolumab works by blocking the interferon receptor on all cells in the body, aiming to reverse the triggering of lupus manifestations wherever they occur. 

Professor Morand said that interferon is associated with other autoimmune diseases such as Scleroderma and Sjogren’s disease, “so there may be potential for trialling anifrolumab in the treatment of other interferon related diseases in the future.”