23 September 2024
Fasenra recommended for approval in the EU by CHMP for the treatment of eosinophilic granulomatosis with polyangiitis
New indication supported by the MANDARA trial which showed nearly 60% of patients achieved remission and 41% of patients fully stopped taking oral corticosteroids
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.1,2
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,3 which compared the efficacy and safety of Fasenra to the only approved EGPA treatment, mepolizumab, in patients with relapsing or refractory EGPA.3-5 MANDARA was the first head-to-head non-inferiority trial of biologics in patients with EGPA.4,6 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.3,4
In the trial, nearly 60% of Fasenra-treated patients achieved remission which was comparable to mepolizumab-treated patients.3 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)).3
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.”
Ruud Dobber, Executive Vice President, BioPharmaceuticals Business Unit, AstraZeneca said: “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.”
The safety and tolerability profile for Fasenra in the MANDARA trial was consistent with the known profile of the medicine.3
Approximately half of patients with EGPA have adult-onset severe eosinophilic asthma (SEA) and often have sinus and nasal symptoms.2,7,8 If approved, Fasenra would be only the second biologic approved to treat this disease.3,4