AstraZeneca’s Fasenra (benralizumab) has been recommended for approval in the European Union (EU) as an add-on treatment for adult patients with relapsing or refractory eosinophilic granulomatosis with polyangiitis (EGPA).

EGPA is a rare, immune-mediated vasculitis that can result in damage to multiple organs, and without treatment, can be fatal.

If approved, Fasenra would become the second biologic approved to treat this disease after GSK’s Nucala (mepolizumab).

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency based its positive opinion on results from the MANDARA Phase III trial published in The New England Journal of Medicine.

MANDARA was the first head-to-head non-inferiority trial of biologics in patients with EGPA, comparing Fasenra to the only approved EGPA treatment, mepolizumab, in patients with relapsing or refractory EGPA.

Patients were randomised to receive either a single 30mg subcutaneous injection of Fasenra, or three separate 100mg subcutaneous injections of mepolizumab every four weeks.

In the trial, nearly 60% of Fasenra-treated patients achieved remission which was comparable to mepolizumab-treated patients.

Data also showed 41% of Fasenra-treated patients fully tapered off oral corticosteroids (OCS) (vs 26% in the comparator arm).

Bernhard Hellmich, Chair of the Department of Internal Medicine, Rheumatology, and Immunology at the Medius Klinik Kirchheim, Teaching Hospital of the University of Tübingen, Co-Director of the Vasculitis Center Tübingen-Kirchhei, and MANDARA Principal Investigator, said: “People living with EGPA in Europe often face debilitating symptoms and suffer serious and long-lasting side effects from treatment with long-term oral corticosteroids. With its unique mechanism of action that leads to near complete depletion of eosinophils, Fasenra represents a much-needed potential treatment option for EGPA patients to help them achieve remission and taper off steroid therapy.”

A convenient treatment for EGPA

Fasenra was recently approved in the US for the treatment of EGPA9 and is also approved as an add-on maintenance treatment for severe eosinophilic asthma (SEA) in more than 80 countries.

It is in development for other diseases including chronic obstructive pulmonary disease, chronic rhinosinusitis with nasal polyps and hypereosinophilic syndrome.

Ruud Dobber, Executive Vice President, BioPharmaceuticals Business Unit, AstraZeneca commented: “With today’s recommendation, the EGPA community in Europe is one step closer to accessing a new and convenient treatment option to alleviate some of the impact of this debilitating disease. With over 15 years of clinical data, Fasenra is a well-established, leading treatment for severe eosinophilic asthma, and now has the potential to transform care for patients with EGPA. Today’s news demonstrates the potential of Fasenra to help patients suffering from eosinophilic diseases beyond severe asthma.”

Diana Spencer, Senior Digital Content Editor, DDW