Shots
- Breztri Aerosphere became the first and only fixed-dose triple-combination maintenance therapy approved in the US for asthma patients aged 12 years and older, expanding beyond COPD and reinforcing the role of single-inhaler triple therapy in advancing asthma care.
- The approval strengthens AstraZeneca’s respiratory portfolio and long-term vision of transforming care beyond symptom control, with additional regulatory reviews underway in the EU, Japan, and China to broaden global patient access.
- PharmaShots welcomes Caterina Brindicci, Senior Vice President & Global Head, Research and Development, Respiratory & Immunology, BioPharmaceuticals R&D, AstraZeneca, and James Teague, Vice President, US Respiratory & Immunology and Vaccine & Immune Therapies, AstraZeneca, for an insightful discussion on Breztri’s US asthma approval, the evolving role of triple therapy, and its potential to redefine the standard of care for uncontrolled asthma.
Saurabh: The recent approval of Breztri Aerosphere in the US marks a pivotal moment in asthma care. From your perspective, what makes this milestone particularly significant for patients and the broader respiratory landscape?
James: Breztri is now the first and only fixed‑dose triple‑combination therapy approved in the US as a maintenance treatment for patients 12 years of age and older with asthma, offering a new option with more comprehensive control in one single inhaler.
With the FDA’s approval Breztri is now indicated for both COPD and asthma, underscoring its versatility across two chronic respiratory diseases impacting millions of Americans. This approval, in addition to Breztri’s position as the fastest‑growing fixed‑dose triple‑combination therapy in COPD globally, reinforces the power of triple therapy to help reshape the standard of care for patients.
Saurabh: With this new asthma indication, how does Breztri strengthen AstraZeneca’s respiratory portfolio and long-term strategy?
Caterina: AstraZeneca’s ambition is to transform respiratory and immunology care for patients – moving beyond symptom control to disease modification, remission and, one day, cure.
The approval of Breztri for asthma in the US is an important step in that journey, providing strong validation that Breztri can offer a meaningful option for patients whose asthma isn’t adequately controlled on dual maintenance therapy, and for patients with or without a prior history of severe exacerbations.
This approval also underscores Breztri’s versatility across chronic respiratory conditions. Given its momentum as the fastest-growing fixed-dose triple-combination therapy in COPD, we’re excited about the potential for Breztri to also help redefine care for people living with asthma.
In addition to this approval in the US, regulatory filings for Breztri in asthma are currently under review in the EU, Japan and China, with the view to broaden access and treatment benefit of inhaled triple therapy to patients around the world.
Saurabh: Given the high prevalence of uncontrolled asthma, how do you anticipate this approval shaping treatment adoption and market dynamics in the US?
James: As the first and only fixed-dose triple-combination therapy approved in the US for patients with asthma 12 years of age and older, Breztri provides a meaningful opportunity to address that gap.
Most importantly, we recognize that achieving optimal outcomes in asthma requires a personalized approach. Patient choice—made in partnership with healthcare professionals—is critical, as it allows individuals to select therapies that best align with their specific needs, preferences, and lifestyles.
Saurabh: Looking ahead, how do you see the role of triple therapy evolving in asthma management, and what impact could this approval have on the future standard of care?
Caterina: Breztri has the potential to evolve the standard of care to more effectively treat asthma in a single inhaled triple therapy compared with dual maintenance therapy. The goal is for triple therapy to help shape a future standard of care where more patients are able to achieve meaningful, sustained asthma control.
About James Teague
James Teague serves as US Vice President for Respiratory, Immunology, Vaccines and Immune Therapies at AstraZeneca, where he leads teams dedicated to delivering innovative medicines that improve patient outcomes.
With broad global experience across the US, EUCAN, China and International Markets, he brings extensive expertise across the product lifecycle, from Phase 2 development through commercialization, spanning respiratory, cardiovascular, oncology and vaccines.
James is passionate about expanding access to care in low- and middle-income countries, advancing screening and diagnostic innovation, and supporting sustainable healthcare solutions.
About Caterina Brindicci
As Senior Vice President & Global Head Research and Development, Respiratory & Immunology, Caterina Brindicci works end-to-end from pre-clinical discovery research through to Phase III, regulatory submission, approval, and subsequently into life cycle management. Caterina leads a global team of +900 inspirational scientists, clinicians, biometrics experts, and regulatory affairs specialists.
Caterina is a Respiratory Physician, holding a PhD in clinical pharmacology and molecular biology from Imperial College London and an MBA from Bocconi University. Health
Caterina plays a pivotal role in AstraZeneca’s BioPharmaceuticals R&D Leadership Team and holds +15 years of experience in senior roles across the pharmaceutical industry. Prior to joining industry, Caterina worked as a Pulmonologist at the National Heart & Lung Institute and Royal Brompton Hospital.
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