Fasenra Approved in the US for Eosinophilic Granulomatosis with Polyangiitis

The FDA has approved AstraZeneca’s Fasenra (benralizumab) to treat adult patients with eosinophilic granulomatosis with polyangiitis (EGPA), a rare vasculitis. The approval is based on the successful MANDARA Phase III trial, which yielded promising results, with nearly 60% of patients achieving remission and 41% discontinuing oral corticosteroids.

EGPA, also known as Churg-Strauss syndrome, is a rare, immune-mediated inflammatory disease that damages small to medium-sized blood vessels and affects multiple organs. The FDA’s approval was based on the findings of the MANDARA trial, which compared Fasenra to mepolizumab, the only other approved treatment for EGPA. In the trial, Fasenra was given as a single 30mg subcutaneous injection every four weeks, whereas mepolizumab was given in three separate 100mg injections.

The successful MANDARA trial demonstrated Fasenra’s efficacy in achieving remission and reducing oral corticosteroid use. Fasenra is already approved for severe eosinophilic asthma in over 80 countries, making its expansion into EGPA a key step in addressing unmet medical needs for eosinophilic diseases.