EC Approves AstraZeneca's Fasenra for Rare Inflammatory Disease EGPA

AstraZeneca’s Fasenra (benralizumab) has received approval from the European Commission (EC) for treating eosinophilic granulomatosis with polyangiitis (EGPA), a rare immune-mediated inflammatory disease affecting around 118,000 individuals globally. This drug is now authorized as an add-on therapy for adults experiencing relapsing or refractory EGPA.

EGPA, previously known as Churg-Strauss syndrome, can cause damage to multiple organs including the lungs, upper airway, skin, heart, gastrointestinal tract, and nerves. Standard treatment often involves chronic high-dose oral corticosteroids, but patients frequently encounter relapses when they try to discontinue these medications.

Fasenra, already approved in the European Union as an add-on maintenance treatment for severe eosinophilic asthma, functions by reducing the survival of eosinophils and basophils through interference with interleukin-5 receptor binding. The recent decision by the EC is based on a recommendation from the European Medicines Agency’s human medicines committee, supported by positive outcomes from the late-stage MANDARA study. In this study, patients were randomized to receive either a single 30mg subcutaneous injection of Fasenra or three 100mg subcutaneous injections of mepolizumab every four weeks.

The study results showed that nearly 60% of patients treated with Fasenra achieved remission, comparable to those receiving mepolizumab. Additionally, 41% of patients on Fasenra were able to completely taper off oral corticosteroids, compared to 26% in the mepolizumab group.

Ruud Dobber, executive vice president of AstraZeneca’s biopharmaceuticals business unit, expressed enthusiasm about the approval. He highlighted that the convenient, single-monthly injection of Fasenra represents significant progress for patients with EGPA. Dobber also noted the drug’s established efficacy in treating severe eosinophilic asthma for many years and expressed satisfaction in offering this new treatment option to EGPA patients in Europe.

This new authorization follows the recent approval of Fasenra by the US Food and Drug Administration (FDA) for treating adults with EGPA. Earlier this year, the FDA also approved the drug for use in children aged six to 11 years with severe eosinophilic asthma and an eosinophilic phenotype.