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In July, FDA accepted a Biologics License Application (BLA) and granted Priority Review for tezepelumab — which is being developed by Amgen in collaboration with AstraZeneca — in the treatment of asthma.
The BLA was based on results from the PATHFINDER clinical trial program, including results from the NAVIGATOR Phase III trial in which tezepelumab demonstrated superiority across every primary and key secondary endpoint compared to placebo in a broad population of patients with uncontrolled asthma.
Mina Makar, Senior Vice President, US Respiratory & Immunology at AstraZeneca (AZ), and Kave Niksefat, VP and General Manager, Inflammation Business Unit at Amgen, talk to Pharm Exec about the potential of tezepelumab and how Amgen and AZ have worked together to develop the treatment.
Pharm Exec: What is the advantage of tezepelumab over existing severe asthma treatments?
Mina Makar: Tezepelumab has the potential to be a novel treatment option that millions of people living with severe asthma need — and deserve. Tezepelumab is a potential first-in-class human monoclonal antibody that works differently than other biologics by inhibiting the action of thymic stromal lymphopoietin or TSLP, a key cytokine that is critical in the initiation and airway inflammations associated with severe asthma. By acting upstream in the asthma inflammatory cascade to block TSLP, tezepelumab has the potential to decrease asthma exacerbations and improve asthma control.
Kave Niksefat: Published in the New England Journal of Medicine (NEJM),1 Phase III NAVIGATOR data reinforced that tezepelumab is the only biologic to consistently and significantly reduce exacerbations in a broad population of severe asthma patients irrespective of the baseline eosinophil counts across Phase II and Phase III clinical trials. These data demonstrate the potential that tezepelumab has for a broad population of people living with severe asthma who are underserved today.
What for you were the most important results from the Phase III Navigator trial of the drug?
Mina Makar: The consistency of efficacy across every endpoint we measure is something I rarely see. In the detailed results from the NAVIGATOR Phase III trial published in the NEJM, tezepelumab versus placebo, demonstrated superiority across every primary and key secondary endpoint in a broad population of patients living with severe asthma, including exacerbations, lung function, asthma control and health-related quality of life. The results build on the strong body of evidence showing the benefit of targeting TSLP at the top of the inflammatory cascade and confirm our plans to bring tezepelumab to a broad population of severe asthma patients across phenotypes and irrespective of biomarkers. Additionally, in the NAVIGATOR trial, tezepelumab achieved an 85% reduction in exacerbations requiring hospitalization, urgent care, or emergency department visits over 52 weeks compared to placebo when added to standard of care.
Can you outline how Amgen and AstraZeneca have worked together on this treatment?
Kave Niksefat: Amgen and AstraZeneca are long-time collaborators, working together since 2012. Tezepelumab is being developed as part of a collaboration between Amgen and AstraZeneca and when we first began working together, tezepelumab’s journey had only just begun. We are very proud of our relationship with AstraZeneca and our complementary strengths. AstraZeneca has a strong global respiratory reach and Amgen brings to bear deep history in novel biologics and manufacturing. AstraZeneca leads development and Amgen leads manufacturing of tezepelumab while the companies co-commercialize in the U.S.
What for you have been the highlights or key milestones of the tezepelumab development journey so far?
Kave Niksefat: Severe asthma is a challenging, complex disease for physicians and millions of patients. Tezepelumab represents a potentially transformative treatment option for a broad population of patients with severe asthma. We are proud to have the New England Journal of Medicine publish and showcase our great results and data from our Phase I, Phase II and Phase III clinical trials and to have received Breakthrough Therapy Designation by the FDA in 2018 and the FDA Priority Review Designation in July 2021. Tezepelumab has also been submitted to regulatory authorities for review in the EU and Japan, with further submissions on track.
Mina Makar: Patients with severe asthma experience frequent exacerbations, significant limitations on lung function and a reduced quality of life. Despite recent advances in asthma, many patients may not qualify for or respond well to current biologic medicines. Tezepelumab was the first asthma biologic to receive Breakthrough Therapy Designation and Priority Review from the FDA. These decisions reinforce the promise of this medicine and bring us a step closer to delivering a much-needed, first-in-class treatment option to people living with severe asthma.
Following the granting of an FDA Priority Review, what is your plan now for getting tezepelumab to patients?
Mina Makar: We are thrilled about the potential that tezepelumab holds for patients and physicians, and we are pleased that tezepelumab was granted Priority Review by the FDA. As we look ahead, we expect to receive a decision from the FDA during the first quarter of 2022. Amgen and AstraZeneca are already working closely together and establishing patient support services to help patients and their HCPs successfully access tezepelumab following FDA approval.
What are your realistic hopes for the treatment in addressing the global socio-economic burden of severe asthma?
Kave Niksefat: It’s clear more now than ever that asthma is a public health issue that’s only increasing around the world as urbanization and air pollution increase. Minority groups continue to bear disproportionate hardships and burdens in managing asthma. For example, Black Americans are five times as likely as white Americans to end up in the Emergency Room or hospitals due to uncontrolled asthma.
Amgen and AstraZeneca are committed to meaningful solutions to advance health equity and reduce health disparities — including efforts to improve diversity in our global clinical trials.