Shots:
- AstraZeneca’s patient-focused immunology vision is reinforced by the EU approval of subcutaneous, self-administered Saphnelo (anifrolimab), offering people with SLE a more convenient option that reduces treatment burden, supports earlier biologic use, and advances the goal of remission beyond symptom control
- The new formulation is expected to improve access, uptake, and adherence while easing infusion capacity constraints, with regulatory expansion underway globally; Saphnelo also anchors a growing pipeline in interferon-driven diseases, alongside next-gen innovations like T-cell engagers and cell therapies aimed at long-term disease transformation
- PharmaShots welcomes Caterina Brindicci for an insightful discussion on AstraZeneca’s immunology strategy, innovation journey, and the evolving landscape of lupus care
Saurabh: How does the introduction of a once-weekly, self-administered pre-filled pen reflect AstraZeneca’s broader patient-centric vision in immunology?
Caterina: Subcutaneous Saphnelo has the potential to make a meaningful difference for people living with Systemic Lupus Erythematosus (SLE). The EU approval takes us another step closer to unlocking Saphnelo’s full potential for patients.
Saphnelo is the cornerstone of our Immunology portfolio. It is our ambition to become a top player in immunology by 2030 and transform immunology care for patients – moving beyond symptom control to disease modification, remission and, one day, cure.
The self-administration of Saphnelo marks a significant advancement toward this ambition by accelerating bio-pen administration and extending the clinically meaningful benefits of Saphnelo in a flexible and convenient way – making remission an achievable goal for more patients with SLE.
Saurabh: Moving Saphnelo from an IV infusion to a self-administered format marks a meaningful shift in lupus care; what were the most important clinical and strategic factors that guided this decision in an evolving SLE treatment landscape?
Caterina: Our clinical goal remains the same across therapeutic options—to deliver meaningful benefit for patients and help make remission a possibility. SLE remains a chronic, complex autoimmune condition with considerable unmet need. Too many patients with lupus worldwide do not receive optimal therapy, and many rely on prolonged use of oral corticosteroids (OCS) and broad immunosuppressive therapies, which may increase the risk of permanent organ damage. Advancements such as self-administration can help improve access to biologic treatments.
Since Saphnelo IV was introduced, achieving DORIS remission has become possible for many more patients with SLE. We’re proud to have seen a paradigm shift in treatment guidelines and recommendations, including recent updates from the European Alliance of Associations for Rheumatology (EULAR) and the American College of Rheumatology (ACR), which now emphasise the importance of reduced oral corticosteroid use and earlier intervention with biologics to reinforce remission as a key treatment goal.
At AstraZeneca, we put patients first. Many patients with SLE face an incredible burden day-to-day, and some must travel long distances to receive their medication in a physician’s office meaning time away from family and work. Self-administration of Saphnelo offers greater flexibility and convenience to a wider group of patients who will now have the choice to receive treatment at home or in the clinic.
We believe that supporting patient choice, in collaboration with healthcare professionals, is essential to achieving optimal treatment outcomes in SLE, as it enables patients to select therapies that best suit their individual needs and lifestyles.
Saurabh: With convenience and access central to this approval, particularly amid infusion capacity constraints across Europe, how do you expect the subcutaneous option to influence treatment uptake, adherence, and real-world outcomes for people living with SLE?
Caterina: We continue to be impressed by the response to, and adoption of, Saphnelo IV infusion in the SLE market. Yet with only 1 in 5 patients with SLE currently receiving a biologic, subcutaneous Saphnelo has significant potential to drive impact for patients. Self-administration of Saphnelo will be a critical component in accelerating the growth of biologics in SLE.
We expect biologic usage in the lupus market to grow, similar to other immune-driven inflammatory diseases such as rheumatoid arthritis, Crohn’s disease or psoriasis, where biologics use among eligible patients (bio-pen) can reach up to 60%.
Saurabh: Following this EU milestone, how is AstraZeneca approaching regulatory expansion for subcutaneous Saphnelo in other key markets, and what insights from the European experience are shaping those plans?
Caterina: Subcutaneous administration of Saphnelo is under regulatory review in several other countries around the world, including the US and Japan. We are excited about the potential for subcutaneous Saphnelo to transform care for patients with SLE and look forward to making it available for more patients as soon as possible following regulatory approvals.
Saurabh: As Saphnelo sits within AstraZeneca’s broader immunology and inflammation portfolio, how does this approval align with your longer-term pipeline strategy across interferon-driven diseases and other high-unmet-need autoimmune conditions?
Caterina: We are pushing the boundaries of science by targeting underlying disease drivers with new mechanisms and modalities, offering the broadest range of treatments to transform patient outcomes.
Our deep understanding of immune dysfunction allows us to challenge current treatment paradigms. With Saphnelo, we’re transforming lupus care, paving the way for it to become the standard of care in SLE.
We are exploring the potential of anifrolimab in a variety of diseases in which type I interferon (IFN) plays a key role. This includes Ph3 studies in lupus nephritis (IRIS trial), cutaneous lupus erythematosus (LAVENDER trial), scleroderma (DAISY trial) and myositis (JASMINE trial).
We’re identifying and targeting the biological drivers that lower disease activity and pioneering new mechanisms and advanced modalities that address the underlying immune response.
Saurabh: Looking ahead, as self-administration and decentralized care reshape chronic disease management, where does AstraZeneca see the next major opportunities in immunology and how are delivery innovation and patient experience influencing your R&D priorities?
Caterina: Our bold ambition is to transform the care of immune-mediated diseases for patients by moving beyond symptom control to long-term remission and one day, cure.
In pursuit of our ambition for cure, we’re accelerating next-generation technologies such as T-Cell Engagers and Cell Therapies with the goal to rebalance – and even “reset” – immune cell function and address the cause of disease. We aim to address the full spectrum of disease severity across immune-mediated diseases.
We are continuously innovating the way we design and deliver clinical trials – putting patients first, listening to their experiences and applying their insights, so that we can design leaner, faster, and more accessible trials for patients.
Saurabh: As immunology moves toward more personalized, home-based, and outcomes-driven care, what does leadership look like in this next chapter, and how is AstraZeneca positioning itself to set the standard rather than follow it?
Caterina: At AstraZeneca, we believe that advancing care in respiratory and immunology is one of the greatest opportunities in healthcare today. Through bold investment, scientific innovation and collaboration across the health ecosystem, we can transform the standard of care, improve patient outcomes and reduce strain on health systems around the world.
We’re tackling the toughest challenges in respiratory and immune-mediated diseases, with end-to-end solutions to address the spectrum of disease severity. With a comprehensive R&I portfolio, we’re delivering tailored solutions that meet the needs of patients.
About the Author:
Caterina Brindicci
Senior Vice President & Global Head Research and Development, Respiratory & Immunology, BioPharmaceuticals R&D, AstraZeneca
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.
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.
Related Post: Enhancing Autoimmune Care: Caterina Brindicci from AstraZeneca in a Riveting Conversation with PharmaShots
