AstraZeneca’s Fasenra Approved in EU for EGPA AstraZeneca’s Fasenra (benralizumab) Approved by EU for Treating Eosinophilic Granulomatosis with Polyangiitis (EGPA) The European Commission (EC) has granted approval for AstraZeneca’s Fasenra (benralizumab) as an add-on treatment for eosinophilic granulomatosis with polyangiitis (EGPA), a rare, immune-mediated inflammatory disease that affects around 118,000 people globally. What is EGPA The newly authorised indication allows Fasenra to be used in adults with relapsing or refractory EGPA, a challenging condition previously known as Churg-Strauss syndrome. EGPA can lead to widespread organ damage, impacting the lungs, upper airway, skin, heart, gastrointestinal tract, and nervous system. A recent study on the burden of EGPA in England found that within six months of diagnosis, over a quarter developed new symptoms, including severe complications like heart failure and neuropathy, highlighting the high disease burden and progression risks. Standard treatments often include chronic high-dose oral corticosteroids, which are effective but can lead to relapses and challenging side effects when patients attempt to reduce or discontinue their use. The EC’s approval of Fasenra for EGPA follows the European Medicines Agency’s (EMA) human medicines committee recommendation based on positive results from the MANDARA Phase 3 study. About MANDARA Phase 3 study In this trial, patients were randomised to receive either a 30 mg subcutaneous injection of Fasenra once a month or three 100 mg subcutaneous injections of mepolizumab every four weeks. Results showed that nearly 60% of Fasenra-treated patients achieved remission, comparable to those treated with mepolizumab. Additionally, 41% of Fasenra patients were able to taper off oral corticosteroids completely, compared to 26% in the mepolizumab group. This new EU authorisation comes shortly after Fasenra received U.S. FDA approval for treating adults with EGPA, further expanding its role as a treatment option in eosinophilic conditions. Earlier this year, the U.S. regulator also approved Fasenra for severe eosinophilic asthma (SEA) in children aged 6 to 11 with an eosinophilic phenotype. It also was recently approved in China for treating SEA. Read the full publication Related news: Fasenra Approved in China For Severe Eosinophilic Asthma Patients Benralizumab's Efficacy in Reducing Eosinophil Count in EoE. Messina Phase 3 Trial Fasenra Outperforms Nucala in EGPA Steroid Reduction: MANDARA Study Findings Manage Cookie Preferences