AstraZeneca's inflammatory disease drug Fasenra approved in the US
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11:35 19/09/24
AstraZeneca has received the green light for its Fasenra drug in the US, used to treat patients with a rare inflammatory disease.
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Fasenra, otherwise known as benralizumab, is used to treat adult patients with eosinophilic granulomatosis with polyangiitis or EGPA – an immune-mediated vasculitis (inflammation of small to medium-sized blood vessels) that can result in damage to multiple organs.
It's estimated that 118,000 people worldwide live with EGPA, affecting around 15,000 in the US, half of which suffer from severe eosinophilic asthma.
The US Food and Drug Administration approved Fasenra following positive results from the MANDARA Phase III trial, which compared the drug to the only approved EGPA treatment, mepolizumab, in patients with relapsing or refractory EGPA.
Nearly 60% of patients in the trial achieved remission, similar to results with mepolizumab, though 41% of Fasenra-treated patients fully tapered off oral corticosteroids compared with 26% in the mepolizumab arm.
"Fasenra is already well established for the treatment of severe eosinophilic asthma, and with this approval, physicians in the US will now be able to offer an important new, convenient single monthly subcutaneous injection to their patients with EGPA," said Ruud Dobber, executive vice president of AstraZeneca's BioPharmaceuticals Business Unit.
"Today's news demonstrates the potential of Fasenra to help patients suffering from eosinophilic diseases beyond severe asthma."