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News - FDA approves Saphnelo autoinjector for self-administration in systemic lupus erythematosus

Image Credit: Saphnelo.

May 2026 | Jack Overell, Head of Production, SAE Media Group

At the end of April, AstraZeneca announcedthat the US Food and Drug Administration (FDA) has approved a new subcutaneous self-administration option for Saphnelo (anifrolumab), expanding treatment access for adults with systemic lupus erythematosus (SLE). The approval covers a once-weekly 120 mg autoinjector, known as the Saphnelo Pen, to be used in addition to standard therapy.

The Saphnelo Pen represents the first subcutaneous, self-administered formulation of the therapy in the US, offering patients greater flexibility in how and where treatment is received.

Approval Based on Phase III TULIP-SC Trial

The FDA decision was supported by data from the Phase III TULIP-SC trial, which evaluated the efficacy and safety of subcutaneous anifrolumab in adults with moderate to severe SLE receiving standard therapy. The study met its primary endpoint, demonstrating a statistically significant and clinically meaningful reduction in disease activity compared with placebo, as measured by the British Isles Lupus Assessment Group–based Composite Lupus Assessment (BICLA) at week 52.

Full trial results were published in Arthritis & Rheumatologyin January 2026. The safety profile of subcutaneous anifrolumab was consistent with the established profile of the intravenous (IV) formulation.

Susan Manzi, MD, MPH, chair of the Allegheny Health Network (AHN) Medicine Institute, director of the Lupus Center of Excellence at the AHN Autoimmunity Institute, and principal investigator of the TULIP-SC trial, said:

“The approval of anifrolumab as a self-administered autoinjector is exciting news as it makes this important medicine more convenient and accessible for many more patients. With its proven ability to significantly reduce disease activity and the risk of organ damage, anifrolumab has been a much-needed innovation in lupus, which is a serious and often debilitating autoimmune condition impacting millions worldwide.”

Expanded Choice for Patients With Lupus

Patient advocacy groups highlighted the importance of the new administration option for people living with lupus.

Louise Vetter, President and Chief Executive Officer of the Lupus Foundation of America, said:

“The FDA approval of a subcutaneous administration option for anifrolumab is an exciting milestone for the lupus community because it offers people with systemic lupus erythematosus more convenience and choice of where and how they want to receive treatment.”

Saphnelo was previously available only as an IV infusion administered by healthcare professionals in a clinical setting. With the introduction of the autoinjector, patients may now self-administer treatment at home or with support from a caregiver or healthcare provider.

AstraZeneca Perspective and Global Use

Ruud Dobber, Executive Vice President, BioPharmaceuticals Business Unit at AstraZeneca, said:

“Since its launch, Saphnelo IV infusion has helped tens of thousands of people with systemic lupus erythematosus achieve lower disease activity with fewer steroids and has been shown to help many achieve remission. The approval of the Saphnelo Pen represents a significant step forward in expanding Saphnelo’s clinical benefits to more people living with systemic lupus erythematosus.”

Saphnelo IV infusion is approved for the treatment of moderate to severe SLE in more than 70 countries, including the US and European Union. To date, more than 40,000 patients worldwide have been treated with Saphnelo. Subcutaneous administration is already approved in the EU and Japan and remains under regulatory review in additional markets.

Saphnelo IV is the first biologic therapy to demonstrate remission data in SLE from a four-year placebo-controlled Phase III trial (TULIP-LTE), using the Definition of Remission in SLE (DORIS) criteria.

About the Saphnelo Pen and Ongoing Research

The Saphnelo Pen delivers a once-weekly 120 mg dose via subcutaneous injection and will also be available as a pre-filled syringe. The therapy is a fully human monoclonal antibody targeting the type I interferon receptor, a key pathway implicated in SLE inflammation.

Beyond SLE, anifrolumab is being evaluated in multiple Phase III clinical trials across other autoimmune conditions, including cutaneous lupus erythematosus, myositis, systemic sclerosis, and lupus nephritis.
 

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Editor’s Corner



WHAT IS CPD?

CPD stands for Continuing Professional Development’. It is essentially a philosophy, which maintains that in order to be effective, learning should be organised and structured. The most common definition is:

‘A commitment to structured skills and knowledge enhancement for Personal or Professional competence’

CPD is a common requirement of individual membership with professional bodies and Institutes. Increasingly, employers also expect their staff to undertake regular CPD activities.

Undertaken over a period of time, CPD ensures that educational qualifications do not become obsolete, and allows for best practice and professional standards to be upheld.

CPD can be undertaken through a variety of learning activities including instructor led training courses, seminars and conferences, e:learning modules or structured reading.

CPD AND PROFESSIONAL INSTITUTES

There are approximately 470 institutes in the UK across all industry sectors, with a collective membership of circa 4 million professionals, and they all expect their members to undertake CPD.

For some institutes undertaking CPD is mandatory e.g. accountancy and law, and linked to a licence to practice, for others it’s obligatory. By ensuring that their members undertake CPD, the professional bodies seek to ensure that professional standards, legislative awareness and ethical practices are maintained.

CPD Schemes often run over the period of a year and the institutes generally provide online tools for their members to record and reflect on their CPD activities.

TYPICAL CPD SCHEMES AND RECORDING OF CPD (CPD points and hours)

Professional bodies and Institutes CPD schemes are either structured as ‘Input’ or ‘Output’ based.

‘Input’ based schemes list a precise number of CPD hours that individuals must achieve within a given time period. These schemes can also use different ‘currencies’ such as points, merits, units or credits, where an individual must accumulate the number required. These currencies are usually based on time i.e. 1 CPD point = 1 hour of learning.

‘Output’ based schemes are learner centred. They require individuals to set learning goals that align to professional competencies, or personal development objectives. These schemes also list different ways to achieve the learning goals e.g. training courses, seminars or e:learning, which enables an individual to complete their CPD through their preferred mode of learning.

The majority of Input and Output based schemes actively encourage individuals to seek appropriate CPD activities independently.

As a formal provider of CPD certified activities, SAE Media Group can provide an indication of the learning benefit gained and the typical completion. However, it is ultimately the responsibility of the delegate to evaluate their learning, and record it correctly in line with their professional body’s or employers requirements.

GLOBAL CPD

Increasingly, international and emerging markets are ‘professionalising’ their workforces and looking to the UK to benchmark educational standards. The undertaking of CPD is now increasingly expected of any individual employed within today’s global marketplace.

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We can provide a certificate for all our accredited events. To request a CPD certificate for a conference , workshop, master classes you have attended please email events@saemediagroup.com

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