FDA Approves Fasenra for Eosinophilic Granulomatosis with Polyangiitis

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The FDA has approved AstraZeneca’s Fasenra (benralizumab) for the treatment of eosinophilic granulomatosis with polyangiitis (EGPA). The regulatory action was based on results from the MANDARA Phase III trial, which demonstrated the efficacy of Fasenra compared to Nucala (mepolizumab), the only other FDA-approved treatment for EGPA. Additionally, these results were published in The New England Journal of Medicine.¹

“This approval is great news for patients with EGPA in the US who continue to suffer from debilitating symptoms. 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,” said Michael Wechsler, MD, MMSc, professor of medicine, director, the Asthma Institute at National Jewish Health, International Coordinating Investigator of the MANDARA trial, in a press release.

The randomized, double-blinded, active-controlled MANDARA trial compared the efficacy and safety of Fasenra to mepolizumab in adult patients with relapsing or refractory EGPA. In this trial, 140 patients were randomly assigned in a 1:1 ratio to receive either a single 30 mg subcutaneous (SC) injection of Fasenra or three separate 100 mg SC injections of Nucala. The primary endpoint of the study was to evaluate the proportion of patients who were in remission at weeks 36 and 48. The secondary endpoint of the study was the proportion of patients who were able to fully taper off oral corticosteroids (OCS) at weeks 48 through 52.

Results demonstrated that nearly 60% of Fasenra-treated patients achieved remission, comparable to Nucala-treated patients. Further, 41% of patients were able to completely taper off OCS compared to 26% of those receiving Nucala.¹

The safety and tolerability of Fansenra was found to be comparable to the established profile of the treatment. Adverse events (AEs) associated with Fasenra include allergic reactions such as anaphylaxis, swelling of the face, tongue, and mouth, issues with breathing, rash, hives, and dizziness. AstraZeneca warns against taking Fasenra if the patient is allergic to it or any of its ingredients.²

“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, Vasculitis Foundation, in the press release.

According to a study by the National Library of Medicine, the prevalence of EGPA per 1,000,000 population was reported as anywhere from 10.7 to 17.8, with an average incidence rate between 0.5 and 3.1.3 In the United States, it is estimated that around 15,000 people are currently living with EGPA, many of whom rely heavily on corticosteroids for symptom management, which can lead to severe AEs.¹

“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. Today’s news demonstrates the potential of Fasenra to help patients suffering from eosinophilic diseases beyond severe asthma,” said Ruud Dobber, EVP, BioPharmaceuticals Business Unit, AstraZeneca, in the press release.

Currently, Fasenra is approved as an add-on maintenance treatment for severe eosinophilic asthma in regions such as the United States, China, Japan, and the EU.¹

References

1. Fasenra approved in the US for eosinophilic granulomatosis with polyangiitis. AstraZeneca. September 18, 2024. Accessed September 18, 2024. https://www.astrazeneca.com/media-centre/press-releases/2024/fasenra-approved-in-the-us-for-eosinophilic-granulomatosis-with-polyangiitis.html

2. Fasenra. Fasenra. Accessed September 18, 2024. https://www.fasenra.com/?source=BEN_C_C_6869&umedium=cpc&uadpub=GOOGLE&ucampaign=NEWUSA_GO_SEM_B_PH_Fasenra-DTC-Consideration-Information&ucreative=Information&uplace=fasenra+information&outcome=NAME&cmpid=1&cid=PPC-accountype:GOOGLE-campaign:NEWUSA_GO_SEM_B_PH_Fasenra-DTC-Consideration-Information-searchterm:fasenra+information-adgroup:Information-keywordid:p76422996627&gclid=Cj0KCQjw9Km3BhDjARIsAGUb4ny4D6TkhOZqGY4ccdOsYySXCDIGN35HsMCV_CIIZdpzK0Oiz6JLdwUaAsC_EALw_wcB&gclsrc=aw.ds&

3. Incidence, Prevalence, and Mortality of Eosinophilic Granulomatosis With Polyangiitis in Korea: A Nationwide Population-Based Study. National Library of Medicine. March 16, 2024. Accessed September 18, 2024. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10973633/#:~:text=The%20prevalence%20of%20EGPA%20per,17.8%20in%20two%20previous%20studies.&text=The%20annual%20incidence%20of%20EGPA,ranges%20from%200.5%20to%203.1.