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AstraZeneca’s Lupus Drug Shows Promise In Mid-Stage Clinical Trial

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Clinical Trial

In response to the promising results, AstraZeneca has already begun a final-stage Phase III clinical trial to test the effectiveness of a 300 mg dose of anifrolumab in patients.

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November 13, 2015 | by Sarah Massey, M.Sc.

AstraZeneca’s experimental lupus drug, anifrolumab, showed positive results at reducing disease activity in a mid-stage clinical trial. The company believes the new treatment has blockbuster potential, and could bring in $1 billion per year in sales.

Anifrolumab was found to be more effective than another experimental treatment – sifalimumab – which was also developed to treat the autoimmune disease. In response to the promising results, AstraZeneca has already begun a final-stage Phase III clinical trial to test the effectiveness of a 300 mg dose of anifrolumab in patients.

If all goes as planned, anifrolumab could be the second newly-approved treatment for lupus in the past 60 years. Benlysta – developed by GlaxoSmithKline – was the last drug approved in 2011. Lupus is an autoimmune disorder in which the patient’s immune system attacks their joints and organs.

AstraZeneca’s anifrolumab was designed for lupus patients with moderate to severe forms of the disease, and is administered via an intravenous injection. Anifrolumab works by targeting interferon – a protein involved in inflammation processes in the body – which is a different mode of action compared to Benlysta.



According to Bing Yao, the head of respiratory, inflammatory and autoimmune research at AstraZeneca's biotech unit MedImmune, anifrolumab has outperformed every other lupus drug that they’ve tested in a mid-stage clinical trial. Anifrolumab was capable of eliciting a response in a Phase IIb clinical trial in 34.4 percent of patients given a 300 mg dose, after 169 days of treatment. This number increased to more than 50 percent after a year of treatment.

“We have been eagerly awaiting clinical data of this magnitude for many years,” said Richard Furie, head of rheumatology at the North Shore-LIJ Health System. AstraZeneca also reported that the lupus treatment reduced the number of patients that needed to take oral corticosteroids.

The mid-stage clinical trial did uncover a few negative side effects of the experimental drug. Patients taking anifrolumab reported an increased incidence of herpes zoster – or shingles – as well as influenza.

Yao commented that these infections can be readily treated using a course of antivirals. If approved, AstraZeneca’s drug could come up against other lupus treatments in development by companies including Anthera Pharmaceuticals an ImmunPharma.

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Keywords:  Clinical Trial, Lupus, Autoimmune


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