FDA Approves Benralizumab for EGPA Vasculitis Indication

The US Food and Drug Administration (FDA) has approved benralizumab (Fasenra) for the treatment of adult patients with eosinophilic granulomatosis with polyangiitis (EGPA), formerly known as Churg-Strauss Syndrome.

The drug is the second approved biologic for the treatment of EGPA. The first, mepolizumab (Nucala), was approved in 2017.

“This disease has a devastating impact on patients and the quality of their life, and they need more treatment options. The approval of another treatment in EGPA is welcome news to the approximately 15,000 patients living in the US with this difficult-to-treat rare disease,” said Joyce Kullman, executive director of the Vasculitis Foundation, in a press release on September 18. 

Benralizumab, developed by AstraZeneca, is a monoclonal antibody against the interleukin-5α receptor expressed on eosinophils. The drug was first approved in 2017 as an add-on treatment for patients 12 years and older with severe eosinophilic asthma, and now is approved for use in children aged 6 years and up. 

The new indication was based on positive results from a noninferiority trial comparing benralizumab and mepolizumab. For the trial, published in the New England Journal of Medicine earlier this year, 140 adult patients with relapsing or refractory EGPA were randomized to receive a 30-mg subcutaneous injection of benralizumab or three separate 100-mg mepolizumab injections every 4 weeks for 1 year. At weeks 36 and 48, 59% of patients in the benralizumab group and 56% of patients in the mepolizumab group achieved remission (95% CI, –13 to 18; P =.73 for superiority). From week 42 through 52, 41% of the patients who received benralizumab completely stopped using oral glucocorticoids, compared with 26% of those who received mepolizumab.

“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,” Michael Wechsler, MD, the director of The Asthma Institute at National Jewish Health in Denver, Colorado, and the international coordinating investigator for the clinical trial, said in the press release.

Benralizumab is administered via subcutaneous injection. In adults with EGPA, the recommended dosage is 30 mg every 4 weeks for the first three doses, then once every 8 weeks.

The most common adverse reactions include headache and pharyngitis, according to the prescribing information. 

Benralizumab is also in development for the treatment of chronic obstructive pulmonary disease, chronic rhinosinusitis with nasal polyps, and hypereosinophilic syndrome.