Monash-led trial of breakthrough drug for Lupus gets FDA approval

A Monash University-led international trial has resulted in US Food and Drug Administration (FDA) approval for a new drug to treat the auto-immune disease lupus - the biggest breakthrough in treatment for the disease in 60 years.

The trial found the drug has significant impact on the skin conditions and arthritis associated with lupus, which affects 20,000 Australians, most of whom are women between the ages of 15 and 45.  It also allows for lower doses of steroids and reduces disease flares

Until now, there has been little treatment for the disease, and no cure.

Monash University Professor Eric Morand, Head of the School of Clinical Sciences and founder of the Monash Lupus Clinic, led the international trial, called TULIP 2, involving more than 360 people with the disease. The results of the study were published in the New England Journal of Medicine in early 2020.

Professor Morand said it is only the second drug approved for the treatment of systemic lupus in 60 years, and it “has effects that are rapid, profound and enduring in controlling the symptoms of the disease”.

Lupus is an autoimmune disease in which the immune system attacks healthy parts of the body. It is particularly prevalent in young women, and has a 10-year mortality of up to 10 per cent.

Professor Morand said: “If you are diagnosed in your early twenties this is a terrible outcome.”

The TULIP 2 trial evaluated AstraZeneca’s anifrolumab and achieved a statistically-significant and clinically-meaningful reduction in disease activity versus placebo, with both arms receiving standard of care.

Professor Morand hopes the Australian Therapeutic Goods Administration regulators will also approve anifrolumab for Australian patients. However, the only other drug to receive TGA approval for lupus is not available on the Pharmaceutical Benefits Scheme (PBS).


About Monash University

Monash University is Australia’s largest university with more than 80,000 students. In the 60 years since its foundation, it has developed a reputation for world-leading high-impact research, quality teaching, and inspiring innovation.

With four campuses in Australia and a presence in Malaysia, China, India, Indonesia and Italy, it is one of the most internationalised Australian universities.

As a leading international medical research university with the largest medical faculty in Australia and integration with leading Australian teaching hospitals, we consistently rank in the top 50 universities worldwide for clinical, pre-clinical and health sciences.

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