AstraZeneca’s Fasenra Approved in EU for Treating Rare Vasculitis, Offering New Hope for EGPA Patients

AstraZeneca’s Fasenra Approved in EU for Treating Rare Vasculitis, Offering New Hope for EGPA Patients

(IN BRIEF) AstraZeneca’s Fasenra (benralizumab) has been approved in the European Union as an add-on treatment for adults with eosinophilic granulomatosis with polyangiitis (EGPA), a rare and severe form of vasculitis. The approval follows positive results from the MANDARA Phase III trial, which showed nearly 60% of patients achieving remission and 41% successfully discontinuing oral corticosteroids. The new indication offers a much-needed treatment option for EGPA patients, complementing Fasenra’s established use in severe eosinophilic asthma. The medication’s safety profile remains consistent with previous data, and it provides a once-monthly injection for ease of use.

(PRESS RELEASE) CAMBRIDGE, 28-Oct-2024 — /EuropaWire/ — AstraZeneca’s Fasenra (benralizumab) has received approval from the European Union (EU) as an add-on therapy for adults with relapsing or refractory eosinophilic granulomatosis with polyangiitis (EGPA), a rare immune-mediated form of vasculitis that can lead to severe organ damage and potentially fatal outcomes if left untreated.

The European Commission’s decision follows a positive recommendation from the Committee for Medicinal Products for Human Use, based on data from the MANDARA Phase III clinical trial. The trial, published in The New England Journal of Medicine, is notable for being the first head-to-head non-inferiority study comparing biologics for EGPA treatment. Patients in the study were randomly assigned to receive either a single 30 mg injection of Fasenra or three 100 mg doses of mepolizumab every four weeks.

Results from the MANDARA trial demonstrated that nearly 60% of patients treated with Fasenra achieved disease remission, a rate similar to that observed in the mepolizumab group. Additionally, 41% of those on Fasenra successfully discontinued oral corticosteroids, compared to 26% in the comparator group, highlighting a significant reduction in corticosteroid dependence.

Bernhard Hellmich, Principal Investigator of the MANDARA trial and a leading expert in internal medicine and rheumatology, emphasized the importance of this new option: “EGPA patients face severe symptoms and the risk of life-threatening complications. The approval of Fasenra provides a crucial treatment option that targets eosinophilic inflammation directly, potentially leading to more patients achieving remission and reducing their reliance on corticosteroids, which carry substantial long-term risks.”

Ruud Dobber, Executive Vice President of AstraZeneca’s BioPharmaceuticals Business Unit, expressed optimism about the approval: “This marks a significant step forward for EGPA patients in Europe. Fasenra’s once-monthly injection provides a convenient and effective treatment option for a condition that is difficult to manage. With Fasenra already established as a leading therapy for severe eosinophilic asthma, we are pleased to extend this option to those with EGPA.”

The safety profile of Fasenra in the MANDARA study aligned with its known tolerability, offering reassurance for its use in this new indication. EGPA often coexists with severe eosinophilic asthma (SEA), making Fasenra a valuable option for patients with overlapping conditions. Fasenra is now the second biologic available for EGPA treatment, following its earlier approval in the United States in September.

Already authorized in over 80 countries as a treatment for SEA, including the US, Japan, and China, Fasenra’s new EU approval for EGPA offers hope to patients facing this challenging and rare disease.

Notes

Eosinophilic granulomatosis with polyangiitis
EGPA, formerly known as Churg-Strauss Syndrome, is a rare, immune-mediated inflammatory disease that is caused by inflammation of small to medium-sized blood vessels.1,2 It is estimated that 118,000 people throughout the world live with EGPA.14 EGPA can result in damage to multiple organs, including lungs, upper airway, skin, heart, gastrointestinal tract and nerves.2 The most common symptoms and signs include extreme fatigue, weight loss, muscle and joint pain, rashes, nerve pain, sinus and nasal symptoms, and shortness of breath.2,15 Without treatment, the disease may be fatal.2 Almost half (47%) of patients do not achieve remission with current treatments.15

There are limited treatment options for EGPA. Patients are often treated with chronic high-dose OCS and experience recurrent relapses when attempting to taper off OCS.16,17

MANDARA
MANDARA was a Phase III, randomised, double-blinded, active-controlled trial, which compared the efficacy and safety of Fasenra to mepolizumab in adult patients with relapsing or refractory EGPA.4 In the trial, 140 patients were randomised 1:1 to receive either a single 30mg subcutaneous injection of Fasenra or three separate 100mg subcutaneous injections of the active comparator every four weeks.3

The primary endpoint was the proportion of patients who were in remission at both weeks 36 and 48.4 Remission is defined as Birmingham Vasculitis Activity Score (BVAS)=0 and OCS dose less than or equal to 4 mg/day.4 A secondary endpoint was the proportion of patients who were able to fully taper off OCS at weeks 48 through 52.3 The primary statistical analysis was to demonstrate non-inferiority of Fasenra versus mepolizumab based on the primary endpoint.3

Fasenra
Fasenra (benralizumab) is currently approved in more than 80 countries, including the US, Japan, EU and China.9-12 Fasenra has been prescribed to over 130,000 patients globally.18

Fasenra is in development for other diseases including chronic obstructive pulmonary disease and hypereosinophilic syndrome.19,20

Fasenra was developed by AstraZeneca and is in-licensed from BioWa, Inc., a wholly owned subsidiary of Kyowa Kirin Co., Ltd., Japan.

AstraZeneca in Respiratory & Immunology
Respiratory & Immunology, part of AstraZeneca BioPharmaceuticals, is a key disease area and growth driver to the Company.

AstraZeneca is an established leader in respiratory care with a 50-year heritage and a growing portfolio of medicines in immune-mediated diseases. The Company is committed to addressing the vast unmet needs of these chronic, often debilitating, diseases with a pipeline and portfolio of inhaled medicines, biologics and new modalities aimed at previously unreachable biologic targets. Our ambition is to deliver life-changing medicines that help eliminate COPD as a leading cause of death, eliminate asthma attacks and achieve clinical remission in immune-mediated diseases.

AstraZeneca
AstraZeneca (LSE/STO/Nasdaq: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialisation of prescription medicines in Oncology, Rare Diseases, and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca’s innovative medicines are sold in more than 125 countries and used by millions of patients worldwide. Please visit astrazeneca.com and follow the Company on social media @AstraZeneca

References

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12. AstraZeneca news release. Available at: https:// www.astrazeneca.com/media-centre/press-releases/2024/fasenra-approved-in-china-for-the-treatment-of-severe-eosinophilic-asthma.html. [Last accessed: October 2024].

13. Fasenra (benralizumab) US prescribing information; September 2024. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761070s021lbl.pdf [Last accessed: October 2024].

14. AstraZeneca Data on file. 2024. REF- 244520.

15. Wechsler ME, et al. Mepolizumab or Placebo for Eosinophilic Granulomatosis with Polyangiitis. N Engl J Med. 2017:376;1921-1932.

16. Baldini C, et al. Clinical Manifestations and Treatment of Churg-Strauss Syndrome. Rheum Dis Clin N Am. 2010;36:527–543.

17. Bell CF, et al. Burden of illness and costs associated with eosinophilic granulomatosis with polyangiitis: evidence from a managed care database in the United States. J Manag Care Spec Pharm. 2021;27(9):1249-1259.

18. AstraZeneca data on file. 2024. REF-235794.

19. Clinicaltrials.gov. Efficacy and Safety of Benralizumab in Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD) With a History of Frequent Exacerbations (RESOLUTE). Available from: https://clinicaltrials.gov/ct2/show/NCT04053634 [Last accessed: October 2024].

20. Clinicaltrials.gov. A Phase 3 Study to Evaluate the Efficacy and Safety of Benralizumab in Patients With Hypereosinophilic Syndrome (HES) (NATRON). Available from: https://clinicaltrials.gov/ct2/show/NCT04191304 [Last accessed: October 2024].

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