Benralizumab approved for treatment of eosinophilic granulomatosis with polyangiitis
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Key takeaways:
- Safety and tolerability were consistent with benralizumab’s known profile.
- Benralizumab is currently approved as an add-on treatment for severe eosinophilic asthma.
The FDA approved AstraZeneca’s Fasenra for the treatment of adult patients with eosinophilic granulomatosis with polyangiitis, or EGPA, according to a company press release.
The approval comes after positive results from the MANDARA phase 3 trial that showed the efficacy and safety of Fasenra (benralizumab) compared with mepolizumab (Nucala, GSK), the only current FDA approved treatment for EGPA.
The MANDARA trial randomly assigned patients with EGPA and administered either a single 30 mg subcutaneous dose of benralizumab (n = 70) or three subcutaneous doses of 100 mg mepolizumab (n = 70) every 4 weeks.
Trial results showed a 59% remission rate among benralizumab patients at weeks 36 and 48, which the company called comparable to the 56% remission rates of the mepolizumab group. Among the benralizumab patients, 41% were also able to fully stop the use of oral corticosteroids, compared with just 26% in the mepolizumab group.
AstraZeneca also said that benralizumab’s safety and tolerability profile in MANDARA was consistent with the biologic’s known profile, with 90% of benralizumab patients and 96% of mepolizumab reporting adverse events including COVID-19 (21% vs. 27%), headache (17% vs. 16%) and arthralgia (17% vs. 11%).
In the press release, Michael Wechsler, MD, MMSc, professor of medicine and director of the Asthma Institute at National Jewish Health, and international coordinating investigator of the MANDARA trial, said that 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,” Wechsler said.
Currently, benralizumab is approved for use as an add-on maintenance treatment for severe eosinophilic asthma.