Key Takeaways
- Fasenra (benralizumab) gains EU approval for treating eosinophilic granulomatosis with polyangiitis (EGPA), providing a new option for patients.
- The approval is based on results from the MANDARA trial, where Fasenra showed a nearly 60% remission rate.
- AstraZeneca’s treatment offers a single monthly injection, helping reduce reliance on corticosteroids.
AstraZeneca’s biologic Fasenra (benralizumab) has received approval from the European Commission as an add-on therapy for adult patients with eosinophilic granulomatosis with polyangiitis (EGPA), a rare, immune-mediated inflammatory disease that affects multiple organs. Without treatment, EGPA can lead to severe complications, including organ damage, and can even be fatal. This new indication follows positive opinions from the Committee for Medicinal Products for Human Use and strong results from the MANDARA Phase III trial, marking a pivotal advancement in treating this challenging disease. Fasenra’s approval provides patients with a more convenient treatment option and represents AstraZeneca’s growing presence in immunology.
The MANDARA trial, a first-of-its-kind head-to-head comparison of biologics in EGPA patients, demonstrated that Fasenra led nearly 60% of participants to remission, a comparable outcome to those treated with mepolizumab, another treatment option for EGPA. In addition, 41% of Fasenra-treated patients fully tapered off oral corticosteroids, compared to just 26% in the comparator arm.
By reducing corticosteroid reliance, Fasenra addresses a major issue for patients who often face adverse side effects from chronic steroid use, which can range from weight gain and bone density loss to heightened infection risks. Dr. Bernhard Hellmich, Principal Investigator of the MANDARA trial, expressed optimism about Fasenra’s potential, stating, “EGPA patients suffer from serious symptoms that impact quality of life and longevity. With Fasenra, we’re able to target eosinophilic inflammation more directly, offering a viable route to remission and less dependency on steroids.”
Clinical Efficacy and Advantages of Fasenra in EGPA Treatment
EGPA, also known as Churg-Strauss Syndrome, is caused by inflammation of small and medium-sized blood vessels, impacting the lungs, skin, and other vital organs. Common symptoms include extreme fatigue, muscle and joint pain, weight loss, and respiratory issues, with almost half of patients failing to reach remission with existing treatments. Fasenra’s approval as only the second biologic treatment for EGPA represents a significant advancement for patients, as the condition has limited treatment options.
Many patients rely on high doses of corticosteroids, which, though effective in controlling inflammation, present a risk of side effects that often lead to poor long-term outcomes. Fasenra’s targeted mechanism of action—binding to and depleting eosinophils, which are responsible for inflammation in EGPA—addresses this challenge by reducing corticosteroid dependency and supporting remission. Ruud Dobber, Executive Vice President of AstraZeneca’s BioPharmaceuticals Business Unit, noted the significance of this approval. “Today’s milestone approval for Fasenra is a promising step for those living with EGPA.
Fasenra, with its single monthly injection, provides a convenient, effective treatment that allows patients to taper off steroids and avoid the associated long-term risks,” he said. Already a well-established therapy for severe eosinophilic asthma, Fasenra has demonstrated a favorable safety and tolerability profile across studies, making it an attractive option for EGPA patients. This approval underscores AstraZeneca’s commitment to developing novel therapies for hard-to-treat conditions, particularly within immunology and respiratory care.
Fasenra’s Broader Implications and AstraZeneca’s Commitment to Immunology
AstraZeneca’s portfolio in Respiratory & Immunology is one of the company’s core growth areas, and Fasenra’s approval for EGPA broadens its impact beyond severe eosinophilic asthma, for which it has been prescribed globally to over 130,000 patients. Fasenra’s novel action of selectively depleting eosinophils, combined with its convenience as a single monthly injection, continues to set it apart as a leading biologic option.
AstraZeneca’s strategic focus on immune-mediated diseases aims to address the significant gaps in treatment options for chronic, often debilitating conditions like EGPA. This expansion not only reflects the company’s research advancements but also supports its goal to transform the lives of patients living with complex immunological diseases. Fasenra’s success in EGPA treatment highlights AstraZeneca’s broader vision of innovation in disease areas with high unmet needs.
Building on its well-established respiratory care expertise, AstraZeneca is making strides to enhance the treatment landscape for immune-related diseases through a robust pipeline of inhaled medicines, biologics, and new therapeutic approaches targeting previously unreachable biologic pathways. As part of its long-term vision, AstraZeneca aims to eliminate severe asthma attacks, improve disease management in chronic obstructive pulmonary disease (COPD), and advance remission in immune-mediated diseases, reinforcing its role as a leader in the biopharmaceutical industry.
Resource: Astrazeneca, October 28, 2024
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