The European Commission (EC) has approved AstraZeneca's Fasenra (benralizumab) as an add-on therapy for adults with relapsing or refractory eosinophilic granulomatosis with polyangiitis (EGPA), a condition previously known as Churg-Strauss syndrome.
Fasenra is the second biologic approved for the condition.
The decision follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) and is supported by results from the MANDARA Phase III study.
EGPA is an uncommon, immune-mediated vasculitis that results from inflammation of small to medium-sized blood vessels, potentially causing multi-organ damage. It can be perilous if left untreated.
Almost 50% of patients with EGPA also suffer from severe eosinophilic asthma and often experience sinus and nasal symptoms.
AstraZeneca bioPharmaceuticals business unit executive vice-president Ruud Dobber stated: “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.”
The randomised, double-blinded, active-controlled MANDARA study evaluated Fasenra's efficacy and safety against mepolizumab in adult subjects with relapsing or refractory EGPA.
It marked the first head-to-head non-inferiority trial of biologics in this patient group.
The trial enrolled 140 patients, randomised into a 1:1 ratio, who received either a single 30mg subcutaneous injection of Fasenra or three distinct 100mg injections of mepolizumab subcutaneously every four weeks.
Almost 60% of patients treated with Fasenra achieved remission, a rate comparable to those treated with mepolizumab.
41% of patients treated with Fasenra completely narrowed down oral corticosteroids (OCS).
The safety and tolerability profile in the MANDARA trial was consistent with the medicine's known profile.
Developed by AstraZeneca and in-licensed from BioWa, a subsidiary of Kyowa Kirin, Fasenra is approved in more than 80 countries and regions, including Japan, the US, the EU and China.
