FDA Approves Fasenra for Treatment of Eosinophilic Granulomatosis with Polyangiitis

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The FDA approved AstraZeneca’s Fasenra (benralizumab) for the treatment of eosinophilic granulomatosis with polyangiitis (EGPA), according to a news release published today.

Fasenra is also approved as an add-on maintenance treatment for adult-onset severe eosinophilic asthma (SEA), which approximately half of EGPA patients have. Fasenra is the second biologic for SEA and is currently approved 80 countries. It has been prescribed to more than 130,000 SEA patients worldwide and in the United States, it is approved for children ages six and up.

EGPA, formerly known as Churg-Strauss syndrome, is a rare autoimmune disease that causes blood vessel inflammation in people with a history of allergies or asthma. With current treatments, almost half of patients with EGPA do not achieve remission. The most common symptoms are extreme fatigue, weight loss and muscle and joint pain. Approximately 15,000 people in the United States and 118,000 people worldwide live with EGPA. It can be fatal if left untreated.

This approval was based on the results of the MANDARA phase 3 trial, which compared the effectiveness of Fasenra to the first FDA-approved EGPA medicine, mepolizumab.

During the trial, 140 patients were given either a single 30 mg subcutaneous injection of Fasenra or three separate 100 mg subcutaneous injections of mepolizumab every four weeks. The full results were published in The New England Journal of Medicine in February. Researchers measured remission at week 36 and 48. A patient was considered in remission if their Birmingham Vasculitis Activity Score (BVAS) was equal to 0 and if they were on an oral corticosteroid dose of less than or equal to 4 mg/day. Forty-one percent of Fasenra patients were able to taper off oral corticosteroids completely, when compared to 26% of patients given mepolizumab.

“This approval is great news for patients with EGPA in the United States who continue to suffer from debilitating symptoms,” Michael Wechsler, M.D., M. M. Sc., director, The Asthma Institute at National Jewish Health and international coordinating investigator of the MANDARA trial said in the news release. “Patients often rely on long-term oral corticosteroids, which can cause serious and lasting side effects. [Fasenra] is a much-needed treatment option, with data showing that not only is remission an achievable goal for EGPA patients, but [Fasenra] can also help patients taper off steroid therapy.”

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