Fasenra Approved in the EU for Eosinophilic Granulomatosis with Polyangiitis
核心洞察
AstraZeneca's Fasenra (benralizumab) has been approved in the EU for adult patients with relapsing or refractory eosinophilic granulomatosis with polyangiitis (搜索) (EGPA (搜索)).
The approval was based on the Phase III MANDARA trial, which demonstrated comparable remission rates between Fasenra and mepolizumab.
Data from the MANDARA trial also showed that 41% of Fasenra-treated patients were able to fully taper off oral corticosteroids (OCS).
AstraZeneca's Fasenra (benralizumab) has received approval in the European Union (EU) as an add-on treatment for adult patients battling relapsing or refractory eosinophilic granulomatosis with polyangiitis (搜索) (EGPA (搜索)), a rare and potentially fatal immune-mediated vasculitis. This decision by the European Commission follows the positive recommendation from the Committee for Medicinal Products for Human Use and is underpinned by compelling results from the Phase III MANDARA trial, marking a significant advancement in the treatment landscape for this challenging condition.
The MANDARA trial, a head-to-head non-inferiority study, randomized patients to receive either a 30 mg subcutaneous injection of Fasenra or three separate 100 mg subcutaneous injections of mepolizumab every four weeks. The results, published in The New England Journal of Medicine, indicated that nearly 60% of Fasenra-treated patients achieved remission, a rate comparable to that observed in the mepolizumab arm. Furthermore, a notable 41% of patients on Fasenra were able to completely discontinue oral corticosteroids (OCS), compared to 26% in the mepolizumab group (difference: 16%; 95% CI: 1,31).
Clinical Impact and Expert Commentary
Bernhard Hellmich, Principal Investigator of the MANDARA trial, emphasized the debilitating nature of EGPA (搜索), highlighting symptoms, organ damage, and the risk of mortality. He stated, "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."
Ruud Dobber, Executive Vice President, BioPharmaceuticals Business Unit, AstraZeneca, added, "Today’s approval of Fasenra, with its convenient, single-monthly injection 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."
Understanding Eosinophilic Granulomatosis with Polyangiitis (EGPA)
EGPA (搜索), previously known as Churg-Strauss Syndrome, affects an estimated 118,000 individuals worldwide. This rare condition involves inflammation of small to medium-sized blood vessels, potentially leading to organ damage affecting the lungs, upper airway, skin, heart, gastrointestinal tract, and nerves. Common symptoms include extreme fatigue, weight loss, muscle and joint pain, rashes, nerve pain, sinus and nasal issues, and shortness of breath. Untreated EGPA can be fatal, and nearly half (47%) of patients do not achieve remission with current treatments, often relying on chronic high-dose OCS, which can lead to recurrent relapses upon tapering.
Details of the MANDARA Trial
The Phase III MANDARA trial was a randomized, double-blinded, active-controlled study comparing Fasenra to mepolizumab in adult patients with relapsing or refractory EGPA (搜索). The trial randomized 140 patients 1:1 to receive either Fasenra 30mg or mepolizumab 100mg subcutaneously every four weeks. The primary endpoint was the proportion of patients in remission at both weeks 36 and 48, defined as a Birmingham Vasculitis Activity Score (BVAS)=0 and OCS dose ≤4 mg/day. A key secondary endpoint was the proportion of patients able to fully taper off OCS at weeks 48-52. The primary statistical analysis aimed to demonstrate non-inferiority of Fasenra versus mepolizumab based on the primary endpoint.
About Fasenra
Fasenra (benralizumab) is approved in over 80 countries, including the US, Japan, EU, and China, and has been prescribed to over 130,000 patients globally. It is also in development for other diseases, including chronic obstructive pulmonary disease and hypereosinophilic syndrome. Fasenra was developed by AstraZeneca and is in-licensed from BioWa, Inc. (搜索), a wholly-owned subsidiary of Kyowa Kirin Co., Ltd.