European Commission Approves AstraZeneca's Fasenra for EGPA Treatment
核心洞察
The European Commission (EC) has approved AstraZeneca's Fasenra (benralizumab) as an add-on treatment for adults with relapsing or refractory eosinophilic granulomatosis with polyangiitis (搜索) (EGPA (搜索)).
Fasenra's approval was supported by the late-stage MANDARA study, demonstrating comparable remission rates to mepolizumab and a higher rate of corticosteroid tapering.
This approval marks a significant advancement, providing a much-needed treatment option for EGPA (搜索) patients in Europe, with a convenient, single-monthly injection.
The European Commission (EC) has granted approval to AstraZeneca's Fasenra (benralizumab) for the treatment of eosinophilic granulomatosis with polyangiitis (搜索) (EGPA (搜索)) in adults. This approval provides a new therapeutic option for patients with relapsing or refractory EGPA, a rare and debilitating immune-mediated inflammatory disease. The decision follows a positive recommendation from the European Medicines Agency's human medicines committee and is based on data from the pivotal MANDARA trial.
EGPA (搜索), formerly known as Churg-Strauss syndrome, affects approximately 118,000 people globally and can cause damage to multiple organs, including the lungs, upper airway, skin, heart, gastrointestinal tract, and nerves. Current treatment often involves chronic high-dose oral corticosteroids, which can lead to significant side effects and recurrent relapses when tapered.
MANDARA Trial Results
The approval of Fasenra was supported by the results of the late-stage MANDARA study. In this trial, patients were randomized to receive either a single 30mg subcutaneous injection of Fasenra or three separate 100mg subcutaneous injections of mepolizumab every four weeks. The study demonstrated that almost 60% of Fasenra-treated patients achieved remission, a rate comparable to those receiving mepolizumab. Notably, 41% of patients treated with Fasenra were able to fully taper off oral corticosteroids, compared to only 26% in the mepolizumab arm.
Ruud Dobber, executive vice president, biopharmaceuticals business unit, AstraZeneca, stated that this approval is a positive step forward for patients with EGPA (搜索), offering a convenient, single-monthly injection. He also noted Fasenra's established use in treating thousands of people with severe eosinophilic asthma (搜索), highlighting the company's commitment to providing much-needed treatment options.
Mechanism of Action
Fasenra is designed to reduce the survival of eosinophils and basophils by interfering with interleukin-5 receptor (搜索) binding. This mechanism helps to reduce the inflammation and organ damage associated with EGPA (搜索).
Prior Approvals
This European approval comes shortly after Fasenra received approval from the US Food and Drug Administration (FDA) for the treatment of adults with EGPA (搜索). The FDA also approved the drug earlier this year for use in severe eosinophilic asthma (搜索) patients aged six to 11 years with an eosinophilic phenotype.