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Global pharmaceutical company AstraZeneca has announced that the European Commission has approved its brand of benralizumab (Fasenra) as an adjuvant therapy for adult patients with relapsing or refractory eosinophilic granulomatosis with polyangiitis (EGPA).

This follows a recent recommendation from European Medicines Agency's Committee for Medicinal Products for Human Use.

The recommendation and subsequent approval are based on results from a Phase III clinical trial coded MANDARA, which showed comparable efficacy when set side by side with mepolizumab, the only approved therapy for management of EGPA.

In the study, approximately 60% of patients who received Fasenra achieved remission, a rate comparable to patients administered with mepolizumab. With further results revealing that 41% of patients on Fasenra fully tapered off oral corticosteroids, a figure superior to the comparator group.

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RELATED: AstraZeneca’s Fasenra set to be approved for eosinophilic granulomatosis treatment

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Eosinophilic granulomatosis with polyangiitis, previously referred to as Churg-Strauss syndrome, affects thousands of people worldwide.

It is an immune-mediated inflammatory disease that arises from inflammation of small to medium-sized blood vessels and can lead to damage to multiple organs or even death.

“People living with EGPA suffer debilitating symptoms, organ damage, and even death. Today’s approval provides an important treatment option for people living with EGPA in the EU. By directly targeting and removing eosinophilic inflammation with benralizumab, I hope that we will see more patients achieve remission as well as a reduction in the reliance on oral corticosteroids, which can cause serious and long-term side effects,” expressed Bernhard Hellmich, Principal Investigator, MANDARA.

Fasenra is already approved in the US for use in the management of EGPA.

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