AstraZeneca’s Fasenra Gains FDA Approval for Treating Eosinophilic Granulomatosis with Polyangiitis

AstraZeneca’s Fasenra (benralizumab) has gained FDA approval for treating eosinophilic granulomatosis with polyangiitis (EGPA) in adult patients. EGPA is a rare and potentially fatal inflammatory vasculitis that can cause damage to multiple organs, including the lungs, heart, and nervous system.

The approval follows positive results from the Phase III MANDARA trial, the first head-to-head study comparing biologics for EGPA. The trial showed Fasenra to be as effective as mepolizumab, the only other approved treatment for EGPA, in achieving remission. Approximately 60% of Fasenra-treated patients reached remission, and 41% were able to fully taper off oral corticosteroids, a significant improvement over the 26% in the mepolizumab group.

Dr. Michael Wechsler, who led the MANDARA trial, highlighted the importance of this approval, noting that Fasenra offers patients a new option that reduces dependence on corticosteroids, which are linked to serious side effects. The approval is expected to benefit the 15,000 patients in the U.S. living with EGPA.

Ruud Dobber, AstraZeneca’s Executive Vice President, emphasized Fasenra’s established role in treating severe eosinophilic asthma and its potential in addressing other eosinophilic conditions. The drug is already approved for severe eosinophilic asthma in more than 80 countries and continues to be developed for other conditions like chronic obstructive pulmonary disease and hypereosinophilic syndrome.

The safety profile of Fasenra in the MANDARA trial was consistent with its known safety record.