Key Highlights:
- AstraZeneca’s drug Fasenra has been approved in the EU as an additional treatment for adults with eosinophilic granulomatosis with polyangiitis (EGPA), a rare immune condition that can cause organ damage.
- Results from the MANDARA Phase III trial showed that nearly 60% of patients treated with Fasenra reached remission and 41% of Fasenra-treated patients fully tapered off oral corticosteroids.
- Fasenra is now the second biologic approved for EGPA treatment and is already approved for SEA in more than 80 countries.

Papisut/Adobe Stock
AstraZeneca’s drug Fasenra (benralizumab) has been approved in the European Union as an additional treatment for adults with eosinophilic granulomatosis with polyangiitis (EGPA), a rare immune condition that can cause organ damage and without treatment, can be fatal.
The approval by the European Commission follows positive results from the MANDARA Phase III trial, which showed that nearly 60% of patients treated with Fasenra reached remission. Data also showed 41% of Fasenra-treated patients fully tapered off oral corticosteroids (OCS) (vs. 26% in the comparator arm (difference: 16%; 95% CI: 1,31)). Positive feedback was also given by the Committee for Medicinal Products for Human Use.
Published in The New England Journal of Medicine, MANDARA was the first head-to-head non-inferiority trial of biologics in patients with EGPA. Patients were randomised to receive either a single 30 mg subcutaneous injection of Fasenra, or three separate 100 mg subcutaneous injections of mepolizumab every four weeks.
Bernhard Hellmich, co-director of the Vasculitis Center Tübingen-Kirchhei and MANDARA principal investigator, said: “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.”
Ruud Dobber, executive vice president, BioPharmaceuticals Business Unit, AstraZeneca added: "We remain committed to helping patients with some of the hardest-to-treat diseases. 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 safety and tolerability profile for Fasenra in the MANDARA trial was consistent with the known profile of the medicine.
Approximately half of patients with EGPA have adult-onset severe eosinophilic asthma (SEA) and often have sinus and nasal symptoms. Fasenra is now the second biologic approved for EGPA treatment and is already approved for SEA in more than 80 countries, including the US, Japan, and China. Fasenra was also approved for EGPA in the US in September.