AstraZeneca Plc has received US approval for a new indication for Fasenra (benralizumab), an antibody therapeutic originally developed for asthma and now authorised to treat eosinophilic granulomatosis with polyangiitis (EGPA), a rare disease caused by inflammation of small to medium-sized blood vessels. Fasenra binds to a subunit of the interleukin-5 receptor which is predominantly expressed on human eosinophils, a type of white blood cell. Although affecting only an estimated 118,000 people globally, the disease can be fatal without treatment.
The Food and Drug Administration approval was based on the results of a Phase 3 trial which compared the safety and efficacy of Fasenra with mepolizumab (Nucala) a treatment developed by GSK Plc. 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. In the trial nearly 60% of patients treated with Fasenra achieved remission, which was comparable to those treated with mepolizumab.
The trial results, which were published in The New England Journal of Medicine on 23 February 2024, also showed that 41% of Fasenra-treated patients no longer needed oral corticosteroids compared with 26% of those in the mepolizumab arm. In a statement, Michael Wechsler, an investigator of the trial, said that patients with EGPA often rely on oral corticosteroids, which can have lasting side effects. He noted that the benralizumab data showing that not only is remission an achievable goal for EGPA patients, but the drug could also help patients taper off steroid therapy. Fasenra is also approved for the treatment of severe eosinophilic asthma.
AstraZeneca received approval for the new indication on 18 September 2024.
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