FDA approves a new drug for the treatment of lupus in the US


This month, the US Food and Drug Administration (FDA) approved anifrolumab, a new drug developed for the treatment of lupus. This is the second drug approved for lupus in the past 60 years and until now, there’s been little specific treatment for the disease. 

Lupus is a complex and heterogeneous disease, so molecular understanding and measuring treatment effects is difficult. Anifrolumab is a potential game-changer for the 20,000 Australians affected by the disease, who are mostly women between the ages of 15 and 45. 

Lupus is a form of rheumatic disease that causes the immune system to attack joints, muscles, bones and organs. 

The young women predominantly affected by lupus face drastic quality-of-life impacts and a shortened life span and are still treated with drugs from the 1950s that have limited benefit and major side-effects. 

Monash University has made major contributions to both the basic science and clinical measurement obstacles. The University investigated in the drug’s TULIP-2 trial, the first positive phase three trial for a lupus drug in 10 years. 

Anifrolumab targets the receptor for type I interferon (IFN), a protein that carries signals from the immune system to the tissues, resulting in inflammation and harm. 

The trial held at Monash University led to results which aided the approval of the drug and validated a long-held belief that IFN has a role in the cause of lupus, opening doors to greater understanding this disease. 

Through the trial, the new drug has been deemed a fast-working and effective treatment, but real-world experience will be key in learning its place in the model of care. 

There was previously an FDA-approved targeted therapy for lupus, however it had low uptake across the globe due to a slow onset of benefit. It’s currently not available in Australia. 

While anifrolumab has been approved in the US and France, it is yet to be confirmed whether the new drug will become available in Australia as well. 

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