FDA Approves AstraZeneca’s Fasenra for Eosinophilic Granulomatosis with Polyangiitis, Offering New Hope for Patients

FDA Approves AstraZeneca’s Fasenra for Eosinophilic Granulomatosis with Polyangiitis, Offering New Hope for Patients

(IN BRIEF) AstraZeneca’s Fasenra (benralizumab) has been approved by the US FDA for the treatment of eosinophilic granulomatosis with polyangiitis (EGPA), a rare immune-mediated vasculitis that can be fatal without treatment. The approval is based on results from the MANDARA Phase III trial, which showed that nearly 60% of patients achieved remission, and 41% were able to stop taking oral corticosteroids. This approval provides a new treatment option for the estimated 15,000 EGPA patients in the US, offering an alternative to long-term corticosteroid use, which is associated with severe side effects.

(PRESS RELEASE) CAMBRIDGE, 18-Sep-2024 — /EuropaWire/ — AstraZeneca today announced that its biologic treatment Fasenra (benralizumab) has been officially approved by the US Food and Drug Administration (FDA) for the treatment of adult patients suffering from eosinophilic granulomatosis with polyangiitis (EGPA). This rare and potentially life-threatening autoimmune condition affects multiple organs, including the lungs, skin, kidneys, and nervous system. The new approval marks a significant advancement for EGPA patients, who now have access to a new treatment option designed to reduce symptoms and improve quality of life.

The approval is based on findings from the Phase III MANDARA trial, which demonstrated Fasenra’s efficacy in helping nearly 60% of patients achieve disease remission. Additionally, 41% of patients treated with Fasenra were able to fully taper off oral corticosteroids (OCS), a common treatment for EGPA that can cause significant long-term side effects. The trial’s results were published in The New England Journal of Medicine.

Addressing the Burden of EGPA

EGPA is a rare form of vasculitis, an inflammation of the blood vessels, which often affects people with severe eosinophilic asthma (SEA). Without treatment, EGPA can lead to irreversible organ damage and even be fatal. For many years, patients have relied on oral corticosteroids to manage their symptoms, but prolonged use of these drugs carries risks, including osteoporosis, high blood pressure, and diabetes. Fasenra’s ability to reduce or eliminate the need for OCS represents a significant breakthrough for patients who have struggled with these debilitating side effects.

Dr. Michael Wechsler, Professor of Medicine and Director of The Asthma Institute at National Jewish Health, and one of the MANDARA trial’s lead investigators, commented on the approval: “Fasenra’s approval is a welcome development for the EGPA community. It offers hope for patients who, for too long, have had to endure the side effects of long-term steroid therapy. This biologic offers a much-needed alternative for managing this challenging condition.”

New Era of Treatment for EGPA Patients

Fasenra has already established itself as a leading treatment option for severe eosinophilic asthma (SEA) since its initial FDA approval. Now, with this new indication for EGPA, AstraZeneca strengthens its position in the treatment of eosinophilic diseases. Fasenra works by targeting eosinophils, the cells responsible for inflammation and tissue damage in EGPA, thereby reducing their numbers and preventing flare-ups.

Ruud Dobber, Executive Vice President of AstraZeneca’s BioPharmaceuticals Business Unit, emphasized the impact of the approval: “Today’s FDA decision enables us to provide an important new treatment option for those living with EGPA. Fasenra’s convenient once-monthly injection can help patients achieve disease remission while reducing their reliance on oral corticosteroids. This underscores AstraZeneca’s commitment to developing therapies that make a meaningful difference in the lives of patients.”

Supporting the Global EGPA Community

Fasenra is only the second biologic approved for the treatment of EGPA, highlighting the limited treatment options available to the approximately 15,000 patients in the US living with this rare disease. Patient advocacy groups, like the Vasculitis Foundation, have welcomed the approval, calling it an essential step in improving the lives of people affected by EGPA.

Joyce Kullman, Executive Director of the Vasculitis Foundation, noted, “For many patients, EGPA can be an overwhelming diagnosis with few effective treatment options. The FDA’s approval of Fasenra brings renewed hope for better disease management and fewer steroid-related side effects.”

Expanding Fasenra’s Role Beyond Severe Asthma

With the addition of EGPA to its approved indications, Fasenra continues to expand its reach within the eosinophilic disease space. Currently, Fasenra is approved for severe eosinophilic asthma in over 80 countries, including the US, Japan, the EU, and China. This latest FDA approval highlights the drug’s potential to address a broader range of eosinophil-driven conditions.

As AstraZeneca prepares for the next chapter in Fasenra’s journey, the company remains focused on driving innovation and delivering treatments that improve patient outcomes. Fasenra’s role in the management of eosinophilic diseases will continue to evolve as research advances and new therapeutic opportunities are explored.

About Fasenra

Fasenra is an add-on maintenance treatment for severe eosinophilic asthma and is now approved for the treatment of eosinophilic granulomatosis with polyangiitis. It is administered via a once-monthly subcutaneous injection, providing patients with a convenient and effective option for managing eosinophilic conditions.

For more information about Fasenra, visit the AstraZeneca website or consult with your healthcare provider.

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.2,3 It is estimated that 118,000 people throughout the world live with EGPA and approximately 15,000 patients living in the US have EGPA.15,16 EGPA can result in damage to multiple organs, including lungs, upper airway, skin, heart, gastrointestinal tract and nerves.3 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.3,17 Without treatment, the disease may be fatal.3,17 Almost half (47%) of patients do not achieve remission with current treatments.18

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.17,19

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.5 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.4

The primary endpoint was the proportion of patients who were in remission at both weeks 36 and 48.5 Remission is defined as Birmingham Vasculitis Activity Score (BVAS)=0 and OCS dose less than or equal to 4 mg/day.5 A secondary endpoint was the proportion of patients who were able to fully taper off OCS at weeks 48 through 52.5 The primary statistical analysis was to demonstrate non-inferiority of Fasenra versus mepolizumab based on the primary endpoint.4

Fasenra
Fasenra (benralizumab) is currently approved in more than 80 countries, including the US, EU, Japan and China.10-13 Fasenra has been prescribed to over 130,000 patients globally.20

Fasenra is in development for other diseases including chronic obstructive pulmonary disease, chronic rhinosinusitis with nasal polyps and hypereosinophilic syndrome.21-23

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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Adrian Kemp, Company Secretary, AstraZeneca PLC

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SOURCE: AstraZeneca