EMA CHMP backs AstraZeneca's Fasenra for EGPA

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has given a positive recommendation for the approval of AstraZeneca’s Fasenra (benralizumab) for the treatment of adults with relapsing or refractory eosinophilic granulomatosis with polyangiitis (EGPA). The decision to endorse Fasenra as an additional treatment option stems from the findings of the Phase III MANDARA clinical trial.

The MANDARA trial evaluated the efficacy and safety of Fasenra in comparison to mepolizumab, which is currently the only approved treatment for EGPA. Participants in this study were randomly assigned to receive either a single 30mg subcutaneous injection of Fasenra or three separate 100mg injections of mepolizumab every four weeks. The results were promising, with nearly 60% of patients treated with Fasenra achieving remission, which was comparable to the results seen in patients treated with mepolizumab.

Moreover, 41% of patients in the Fasenra group were able to completely discontinue the use of oral corticosteroids, a notable improvement over the 26% in the comparator group. The safety and tolerability profile of Fasenra observed in the trial was consistent with its known characteristics.

Fasenra has already been approved in the United States for the treatment of EGPA and is also commonly used as an additional maintenance treatment for severe eosinophilic asthma in more than 80 countries, including the US, Japan, the European Union, and China. Additionally, it has been approved for use in children and adolescents aged six and above in both the US and Japan.

Ruud Dobber, the executive vice-president of AstraZeneca’s BioPharmaceuticals Business Unit, expressed optimism regarding the CHMP’s recommendation. He 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.” Dobber highlighted that Fasenra, which is supported by over 15 years of clinical data, is already a leading treatment for severe eosinophilic asthma and has the potential to significantly improve care for patients with EGPA. He noted, “The news demonstrates the potential of Fasenra to help patients suffering from eosinophilic diseases beyond severe asthma.”

This development follows another recent approval by the US Food and Drug Administration for AstraZeneca’s FluMist, a needle-free nasal spray influenza vaccine designed for self-administration.