The European Commission has granted approval to Fasenra (benralizumab) as an add-on treatment for adult patients with relapsing or refractory eosinophilic granulomatosis with polyangiitis (EGPA). The approval follows the positive opinion issued by the EMA’s Committee for Medicinal Products for Human Use (CHMP) a month prior.
EGPA is a rare disease caused by the inflammation of small blood vessels, also known as vasculitis, which restricts blood flow and can cause damage across multiple organs and can be fatal if left untreated. It is estimated that approximately 47% of patients are not able to achieve remission with currently available treatments, which often rely on high doses of oral corticosteroids.
In the MANDARA phase 3 clinical trial, the efficacy of Fasenra was compared to that of mepolizumab, an antibody drug approved for the treatment of EGPA. The trial recruited 140 patients that received either a single dose of Fasenra or three doses of mepolizumab delivered every four weeks.
Nearly 60% of patients treated with Fasenra achieved remission, which was comparable to the results achieved with its competitor mepolizumab. In addition, 41% of patients who received Fasenra were able to fully taper off oral corticosteroids, compared to 26% of patients treated with mepolizumab.
“People living with EGPA suffer debilitating symptoms, organ damage and even death. Today’s approval provides an important treatment option for people living with EGPA in the EU. By directly targeting and removing eosinophilic inflammation with benralizumab, 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.” said Bernhard Hellmich, Department Chair at Medius Klinik Kirchheim and Principal Investigator of the MANDARA clinical trial.
Fasenra’s EU approval closely follows its US approval in September. The antibody drug is also approved in more than 80 countries as an add-on maintenance treatment for severe eosinophilic asthma (SEA), which typically affects about half of patients with EGPA.
“Today’s approval of Fasenra, with its convenient, single-monthly injection, is a positive step forward for patients with EGPA. Fasenra has been a well-established treatment for many years in thousands of people with severe eosinophilic asthma and we are pleased to now offer a much-needed treatment option for those living with EGPA in Europe,” said Ruud Dobber, Executive Vice President of the Biopharmaceuticals Business Unit at AstraZeneca.
