FDA Approves Benralizumab for Eosinophilic Granulomatosis with Polyangiitis
The approval was based on data from the phase 3 MANDARA trial, where the therapy met the primary endpoint of proportion of patients in remission at weeks 36 and 48.
The FDA has approved benralizumab (Fasenra) for the treatment of eosinophilic granulomatosis with polyangiitis (EGPA) in adult patients, AstraZeneca announced in a release.1 The decision makes the therapy the second approved to treat the rare disease in the United States, with the other being GSK’s mepolizumab (Nucala).
FDA Approves Benralizumab for Eosinophilic Granulomatosis with Polyangiitis / Tada Images - stock.adobe.com
The approval of benralizumab was based on data from the phase 3 MANDARA (NCT04157348) trial, in which the therapy met the primary endpoint of proportion of patients in remission at both weeks 36 and 48. Benralizumab also met its secondary endpoint of proportion of patients able to fully taper off of oral corticosteroids at weeks 48 through 52. Data from the study was published in The New England Journal of Medicine.2
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“This approval is great news for patients with EGPA in the US who continue to suffer from debilitating symptoms,” Michael Wechsler, professor of medicine and director of The Asthma Institute at National Jewish Health, said in a release.1 “Patients often rely on long-term oral corticosteroids, which can cause serious and lasting side effects. Benralizumab is a much-needed treatment option, with data showing that not only is remission an achievable goal for EGPA patients, but benralizumab can also help patients taper off steroid therapy.”
MANDARA was a randomized, double-blinded, active-controlled phase 3 trial that compared the efficacy and safety of benralizumab to mepolizumab in adults with relapsing or refractory EGPA. The study cohort included 140 patients who randomly received either a single 30 mg subcutaneous injection of benralizumab or 3 separate 100 mg subcutaneous injections of mepolizumab every 4 weeks. The primary statistical analysis was to demonstrate non-inferiority of benralizumab versus mepolizumab.
The study found that the adjusted percentage of patients with remission at weeks 36 and 48 was 59% in the benralizumab group and 56% in the mepolizumab group. During weeks 48 through 52, complete withdrawal of oral corticosteroids was achieved in 41% of patients who received benralizumab and 26% of those who received mepolizumab. Additionally, the accrued duration of remission and the time to first relapse were similar between both groups.
The safety and tolerability of benralizumab was seen to be consistent with the known profile of the therapy. During the trial, 90% of the patients in the benralizumab group and 96% of those in the mepolizumab group reported adverse events. Serious adverse events were reported in 6% of patients in the benralizumab group and 13% of patients in the mepolizumab group.
“Fasenra is already well established for the treatment of severe eosinophilic asthma, and with this approval, physicians in the US will now be able to offer an important new, convenient single monthly subcutaneous injection to their patients with EGPA,” Ruud Dobber, executive vice president of the Biopharmaceuticals Business Unit at AstraZeneca, said in a release.1 “Today’s news demonstrates the potential of FASENRA to help patients suffering from eosinophilic diseases beyond severe asthma.”
EGPA, which was formerly known as Churg-Strauss Syndrome, is rare form of immune-mediated vasculitis. It tends mostly to impact those who have a history of severe allergies and/or asthma. Although the disease has been reported in very young or elderly patients, it is most common in patients between the ages of 38 and 54. The disease has a prevalence of 1 to 3 per million adults globally and can be fatal without treatment.3
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