The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended approving AstraZeneca’s Fasenra (benralizumab) to treat adults with relapsing or refractory eosinophilic granulomatosis with polyangiitis (EGPA).
The CHMP's positive opinion for the use of Fasenra as an add-on treatment was based on the results from the Phase III MANDARA clinical trial.
The trial assessed the efficacy and safety of Fasenra in line with mepolizumab, the only other approved treatment.
Patients were assigned to receive either a single 30mg subcutaneous injection of the therapy or three separate 100mg mepolizumab injections every four weeks.
Almost 60% of subjects treated with Fasenra achieved remission, aligning with the results for mepolizumab-treated patients.
41% of those on Fasenra were able to fully taper off oral corticosteroids, compared to 26% in the comparator arm.
Fasenra’s safety and tolerability in the trial were in line with its known profile.
The product is already approved in the US for EGPA treatment and as an add-on maintenance treatment for severe eosinophilic asthma in more than 80 countries and regions, including the US, Japan, the EU and China.
It is also approved for use in children and adolescents aged six and above in the US and Japan.
AstraZeneca BioPharmaceuticals Business Unit executive vice-president Ruud Dobber stated: “With the 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. The news demonstrates the potential of Fasenra to help patients suffering from eosinophilic diseases beyond severe asthma.”
The latest development comes after the US Food and Drug Administration approved AstraZeneca‘s FluMist, a needle-free nasal spray influenza vaccine for self-administration.
