Fasenra Approved in EU for Eosinophilic Granulomatosis with Polyangiitis
核心洞察
The European Commission has approved Fasenra (benralizumab) as an add-on treatment for adult patients with relapsing or refractory eosinophilic granulomatosis with polyangiitis (搜索) (EGPA (搜索)).
In the MANDARA phase 3 clinical trial, nearly 60% of patients treated with Fasenra achieved remission, comparable to mepolizumab, with 41% able to taper off oral corticosteroids.
Fasenra's EU approval follows its US approval in September and its existing approval in over 80 countries as an add-on maintenance treatment for severe eosinophilic asthma (搜索) (SEA (搜索)).
AstraZeneca's Fasenra (benralizumab) has received approval from the European Commission as an add-on treatment for adult patients suffering from relapsing or refractory eosinophilic granulomatosis with polyangiitis (搜索) (EGPA (搜索)). This decision follows a positive recommendation from the EMA’s Committee for Medicinal Products for Human Use (CHMP) a month prior, marking a significant advancement in the treatment of this rare and potentially fatal disease.
EGPA (搜索), a rare autoimmune condition characterized by the inflammation of small blood vessels (vasculitis), restricts blood flow and can cause damage to multiple organs. Current treatments often rely on high doses of oral corticosteroids, but approximately 47% of patients fail to achieve remission with these therapies.
MANDARA Trial Results
The approval was supported by data from the MANDARA phase 3 clinical trial, which compared the efficacy of Fasenra to mepolizumab, another antibody drug approved for EGPA (搜索) treatment. The trial involved 140 patients who were administered either a single dose of Fasenra or three doses of mepolizumab every four weeks.
The results indicated that nearly 60% of patients treated with Fasenra achieved remission, a rate comparable to that observed with mepolizumab. Furthermore, 41% of patients receiving Fasenra were able to completely discontinue oral corticosteroids, compared to 26% in the mepolizumab group.
Expert Commentary
Bernhard Hellmich, Department Chair at Medius Klinik Kirchheim and Principal Investigator of the MANDARA clinical trial, stated, “People living with EGPA (搜索) suffer debilitating symptoms, organ damage, and even death. Today’s approval provides an important treatment option for people living with EGPA in the EU... I hope that we will see more patients achieve remission as well as a reduction in the reliance on oral corticosteroids, which can cause serious and long-term side effects.”
Global Impact and Existing Approvals
Fasenra's EU approval closely follows its US approval in September. The drug is also approved in over 80 countries as an add-on maintenance treatment for severe eosinophilic asthma (搜索) (SEA (搜索)), which commonly affects about half of patients with EGPA (搜索). The convenient, single-monthly injection offers a positive step forward for patients with EGPA.
Ruud Dobber, Executive Vice President of the Biopharmaceuticals Business Unit at AstraZeneca, commented, “Today’s approval of Fasenra... is a positive step forward for patients with EGPA (搜索). Fasenra has been a well-established treatment for many years in thousands of people with severe eosinophilic asthma (搜索) and we are pleased to now offer a much-needed treatment option for those living with EGPA in Europe.”