EGPA Remission with Fasenra: Michael Wechsler and Andrew Menzies Gow in Conversation with PharmaShots

Shots:

An already established biologic treatment for SEA in the US, EU5 & Japan. Fasenra is now showing exemplary remission for the treatment of Eosinophilic Granulomatosis with Polyangiitis (EGPA)
Today, at PharmaShots, we have a distinguished panel of speakers shedding light on advancements under the P-III MANDARA study and the recent publication of the study in The New England Journal of Medicine
On the panel, we have Andrew Menzies Gow, Dr. Michael Wechsler, and AstraZeneca’s Fasenra team

Saurabh: To begin with, what are the advancements made under the P-III (MANDARA) clinical trial evaluating Fasenra (benralizumab) for the treatment of Eosinophilic Granulomatosis with Polyangiitis (EGPA)? 

Michael: MANDARA is the first head-to-head trial of biologics in patients with eosinophilic granulomatosis with polyangiitis (EGPA) and the first to demonstrate that remission is an achievable treatment goal for EGPA patients with eosinophil-targeting biologic therapies. 

Only one third of eligible EGPA patients are currently receiving an approved treatment (in the top seven countries), while patients treated with high-dose OCS) often experience serious and lasting side-effects, as well as recurrent relapses when attempting to taper off.   

Having another treatment option that could help patients achieve remission and reduce chronic OCS usage, could alleviate some of the impact of this debilitating disease.  

Saurabh: Please update our reader on the insights from the P-III (MANDARA) clinical trial. Are there any additional results that will potentially support the approval of Fasenra?   

Michael: Fasenra met the primary endpoint of non-inferiority to mepolizumab and demonstrated that remission is an achievable treatment goal for EGPA patients.   

The MANDARA results also showed that Fasenra allowed a higher proportion of patients to taper off OCS versus the current biologic standard, while treatment with Fasenra was associated with a greater reduction of blood eosinophil counts. 

Saurabh: How has the publication in The New England Journal of Medicine and your presentation at the AAAAI 2024 contributed to bringing Fasenra to the attention of patients with Eosinophilic Granulomatosis with Polyangiitis?

Andrew: Recognizing the daily challenges faced by the patient communities living with inflammatory disorders like EGPA, research such as MANDARA aims to redefine patient care and bridge gaps in understanding for a better quality of life. 

This publication and further exposure of the trial data at AAAAI not only increases awareness of EGPA, but it also encourages action to address the high unmet need among patients with EGPA and expand treatment options. 

Saurabh: In a previous interview with PharmaShots, AstraZeneca discussed the possibility of assessing the potential of Fasenra as a treatment across several other diseases. Are there any updates on that? 

Andrew: We are exploring Fasenra’s potential to treat the diseases associated with eosinophilic inflammation and are committed to improving patient outcomes in EGPA and other diseases. Fasenra is in development for other diseases including  chronic obstructive pulmonary disease, chronic rhinosinusitis with nasal polyps and hypereosinophilic syndrome. Our ambition is to build on the position Fasenra has already achieved in SEA to be the first-line, first-choice biologic for eosinophil-driven diseases.  

Saurabh: The company was expecting a regulatory submission by the H2 2023. What are the updates on the regulatory submission and approval of Fasenra for EGPA? 

AstraZeneca’s Fasenra Team: As shared in Q4 results, we are currently seeking approval for the EGPA indication in the EU, US and Japan. Thus far, Fasenra has achieved blockbuster status and is the leading biologic SEA treatment in US, EU5, Japan. 

Saurabh: As Eosinophilic Granulomatosis with Polyangiitis (EGPA) is a rare disorder, are there any plans to provide patient support programs or other programs for spreading awareness among these patients? 

AstraZeneca’s Fasenra Team: We remain committed and confident in Fasenra’s potential for patients and frequently work with patient advocacy groups to identify opportunities to support patients.

Image Source: Canva

About the Author:

Andrew Menzies Gow

Andrew Menzies-Gow is the Global Medical Head for Respiratory Biologics at Astra Zeneca. Prior to joining the company in January 2023 Andrew was the clinical and research lead for the severe asthma service and Director of the Lung Division at the Royal Brompton & Harefield Hospitals, London, UK. Andrew was a Professor of Practice (Respiratory Medicine) at Imperial College, London, UK, where his research interests focussed on novel therapies for severe asthma and was the National Clinical Director for Respiratory Disease at NHS England.

Michael Wechsler

Dr. Michael Wechsler is Professor of Medicine, Director of the National Jewish Health (NJH)/Cohen Family Asthma Institute. He is also Director of the Asthma Program in the Division of Pulmonary, Critical Care and Sleep Medicine at NJH. He is a member of the Steering Committee and site Principal Investigator of the NIH-sponsored Asthma Clinical Research Network (ACRN, now called AsthmaNet), a multicenter asthma clinical trials consortium, and of the Precision Intervention in Severe/Exacerbating Asthma (PRECISE) network. A member of the American Society of Clinical Investigation, he has participated in many different task forces related to the study of eosinophilic lung diseases that were sponsored by the NIH, the US Food and Drug Administration, the European Respiratory Society, and the International Eosinophil Society. Professor Wechsler’s research focuses on clinical and translational asthma with emphasis on clinical trials in asthma, novel asthma therapies, bronchial thermoplasty, asthma pharmacogenomics, and management of eosinophilic granulomatosis with polyangiitis (Churg-Strauss Syndrome, CSS). He has led studies focusing on novel biologic agents for asthma and related diseases, including benralizumab, dupilumab, mepolizumab, and reslizumab. He has published more than 170 peer-reviewed manuscripts relating to asthma, CSS, and eosinophilic lung diseases. Professor Wechsler serves as Associate Editor of the Journal Allergy and is on the editorial Board of the European Journal of Clinical Investigation. Dr. Wechsler received AB and MMSc degrees from Harvard University in Boston and his medical degree from McGill University in Montreal.