A Multicentre, Randomised, Open-label, Phase I Study to Characterise the Pharmacokinetics, Pharmacodynamics, and Safety of Anifrolumab Administered Subcutaneously or Intravenously in Participants With Systemic Lupus Erythematosus

The purpose of this study is to assess the PK, PD, and safety of anifrolumab as SC administration or IV infusion in adult participants with systemic lupus erythematosus (SLE).

Start Date30 Oct 2026

Sponsor / Collaborator

AstraZeneca PLC

[+1]

NCT07431775

/ Not yet recruitingNot Applicable

A Non-Interventional Descriptive Multi-Country Study of Saphnelo™ (Anifrolumab-fnia) Utilization in Females of Reproductive Potential

Systemic lupus erythematosus (SLE) is a chronic autoimmune disease characterized by substantial clinical burden-including organ damage, increased morbidity, and mortality-that often presents in young adulthood and disproportionately affects female patients. SAPHNELO™ (anifrolumab-fnia), a fully human IgG1 κ monoclonal antibody, is a novel therapeutic option approved for add-on treatment of moderate-to-severe SLE in the United States (US) on 30 July 2021 and in the European Union on 14 February 2022. To fulfill US Food and Drug Administration (FDA) post-marketing requirements for the evaluation of anifrolumab safety in pregnancy, additional evidence is needed to better understand the real-world drug utilization of anifrolumab in female patients of reproductive potential.

Start Date01 Oct 2026

Sponsor / Collaborator

AstraZeneca PLC

[+1]

NCT07691970

/ Not yet recruitingPhase 3

ROSY-S: Rollover Study for Participants Who Have Completed a Previous Study With Anifrolumab (Saphnelo) and Are Assessed by the Investigator to Clinically Benefit From Continued Treatment

The purpose of this study is to provide continued access to anifrolumab to eligible participants who are continuing to derive clinical benefit from treatment at the end of a parent clinical study, as assessed by the Investigator, while monitoring safety and tolerability.
Study details include:
* Participants can transition in ROSY-S once they complete their participation in the parent study and should have received at least one dose of anifrolumab in the parent study. Participants with a treatment gap from parent studies and/or who are on compassionate use are eligible to rollover to ROSY-S study.
* The earliest that the Enrolment Visit may occur is at the time of the last visit of the parent study (ie, completion of the parent study's final safety follow-up visit). All required assessments from the safety follow-up visit of the parent study must be completed before the Enrolment Visit of ROSY-S study.
* The participants will continue to receive anifrolumab the same way they received it in the parent trial
* A participant is considered to have completed the study when they meet one of the discontinuation criteria.
* Safety will be monitored throughout the study. Both serious and nonserious AEs will be collected up to 12 weeks after the last dose of anifrolumab and will be reported as part of the primary safety endpoint.

Start Date01 Sep 2026

Sponsor / Collaborator

AstraZeneca PLC

100 Clinical Results associated with Anifrolumab-FNIA

100 Translational Medicine associated with Anifrolumab-FNIA

100 Patents (Medical) associated with Anifrolumab-FNIA

387

Literatures (Medical) associated with Anifrolumab-FNIA

01 Sep 2026·ANNALES DE DERMATOLOGIE ET DE VENEREOLOGIE

Anifrolumab for refractory cutaneous manifestations of amyopathic dermatomyositis

Letter

Author: Seneschal, J ; Doutre, M-S ; Horiot, V ; Truchetet, M-E ; Toussaint, C

01 Aug 2026·SEMINARS IN ARTHRITIS AND RHEUMATISM

Efficacy and safety of belimumab and anifrolumab in systemic lupus erythematosus: A systematic review and network meta-analysis

Review

Author: Murad, M Hassan ; Martinez-Martinez, Marco U ; Duarte-García, Alí ; Crowson, Cynthia S ; Tejada-Llacsa, Paul J ; Prokop, Larry J

OBJECTIVES:

To compare the efficacy and safety of belimumab and anifrolumab in adult patients with SLE.

METHODS:

We conducted a systematic review and network meta-analysis (NMA) of randomized controlled trials (RCTs) in SLE. We included RCTs comparing belimumab or anifrolumab plus standard of care versus placebo plus standard of care. Outcomes included SRI-4, BICLA, selected BILAG organ-domain responses, and safety endpoints; belimumab BICLA data were derived from post hoc analyses. Odds ratios (ORs) with 95% confidence intervals (CIs) were estimated. Risk of bias was assessed with RoB 2; certainty in network estimates was evaluated using the GRADE approach as applied in the CINeMA framework.

RESULTS:

Eleven trials (n = 8607) were included (4 anifrolumab; 7 belimumab, including 2 safety-only trials). Both biologics were associated with higher odds of achieving an SRI-4 response than placebo: anifrolumab OR 1.78 (95% CI 1.41-2.24); belimumab OR 1.62 (95% CI 1.38-1.90), with no significant difference between active treatments. For BICLA, anifrolumab was superior to belimumab (OR 1.56, 95% CI 1.10-2.21). Mucocutaneous and musculoskeletal responses favored both biologics versus placebo, whereas renal and cardiovascular/respiratory effects were not statistically significantly different. In safety analyses, SAEs and serious infections were similar between biologics, whereas herpes zoster was higher with anifrolumab versus belimumab (OR 4.74, 95% CI 2.00-11.21).

CONCLUSION:

In this NMA, anifrolumab and belimumab achieved similar SRI-4 responses. Anifrolumab showed a higher BICLA response than belimumab, but this finding should be interpreted cautiously given reliance on indirect evidence and moderate certainty. Clinically, these data support individualized biologic selection, weighing potential benefit on BICLA against the consistently higher herpes zoster risk with anifrolumab.

01 Aug 2026·LUPUS

Comparative study of adverse drug reactions associated with anifrolumab and belimumab for the treatment of systemic lupus erythematosus

Article

Author: Chiappetta, Maria Rachele ; Castellana, Eleonora

Background:

Anifrolumab and belimumab are the two biologic agents currently approved for moderate-to-severe systemic lupus erythematosus (SLE), targeting distinct immunological pathways. While their efficacy has been established in randomized controlled trials, their comparative safety profiles in real-world settings remain incompletely characterized.

Methods:

A retrospective pharmacovigilance study was conducted using data from the FDA Adverse Event Monitoring System (AEMS) from January 1, 2011 to March 30, 2026. Individual Case Safety Reports (ICSRs) were extracted using “anifrolumab,” “anifrolumab-Fnia,” and “belimumab” as search terms. Adverse drug reactions (ADRs) were coded according to MedDRA version 28.1 Preferred Terms. A disproportionality analysis was performed using the Reporting Odds Ratio (ROR) with 95% confidence intervals; a p-value <0.05 was considered statistically significant.

Results:

A total of 2124 ICSRs for anifrolumab and 30,107 for belimumab were identified. Female patients predominated in both groups, consistent with SLE epidemiology. Herpes zoster showed a strong and statistically significant association with anifrolumab (ROR = 5.13; 95% CI: 3.97–6.62; p < 0.0001), consistent with its type I interferon receptor antagonism mechanism. Belimumab was more frequently associated with administration-related events, including missed doses, device misuse, and injection site pain. No statistically significant differences were observed for fatigue, arthralgia, headache, nausea, or rash.

Conclusions:

Anifrolumab and belimumab exhibit distinct safety profiles. Anifrolumab carries a significantly higher risk of herpes zoster infection, warranting pre-treatment vaccination assessment. Belimumab shows a predominance of administration-related and non-serious events. Treatment selection should be individualized based on patient-specific risk factors, infection susceptibility, and adherence considerations.

News (Medical) associated with Anifrolumab-FNIA

09 Jul 2026

·www.prnewswire.com

Systemic Lupus Erythematosus Market at a Turning Point as 6 Late-Stage Emerging Therapies Set to Redefine Treatment Landscape | DelveInsight

Companies like Biogen and Royalty Pharma (Litifilimab), Biogen and UCB (Dapirolizumab pegol), Idorsia Pharmaceuticals and Viatris (Cenerimod), Novartis (Ianalumab, YTB3231), Kyowa Kirin (KK-4277), and others are advancing late, mid, and early-stage drugs, showing promise in the systemic lupus erythematosus treatment market. LAS VEGAS, July 9, 2026 /PRNewswire/ -- Systemic lupus erythematosus (SLE) is a chronic, complex autoimmune disease that can affect multiple organ systems, with disease severity and clinical manifestations varying considerably among patients. Despite significant advances in understanding its pathophysiology, SLE remains incurable, and current treatment strategies primarily focus on controlling disease activity, achieving remission or low disease activity, preventing irreversible organ damage, minimizing flares, and improving patients' long-term quality of life. The therapeutic landscape for SLE remains limited, with only two therapies currently approved by the US FDA specifically for the disease: BENLYSTA (belimumab) from GlaxoSmithKline and SAPHNELO (anifrolumab) from AstraZeneca. Conventional treatment continues to rely on nonsteroidal anti-inflammatory drugs (NSAIDs), antimalarial agents, glucocorticoids, immunosuppressants, and other supportive therapies. While glucocorticoids remain a cornerstone of disease management, their well-documented long-term toxicities have intensified efforts to reduce steroid exposure through treat-to-target strategies. The persistent need for multiple lines of therapy and the limitations associated with existing treatments highlight the substantial unmet need for safer and more effective disease-modifying options. Discover what is the future of the systemic lupus erythematosus (SLE) drugs market @ The SLE pipeline is robust and increasingly diverse, with several late-stage and emerging therapies targeting novel immune pathways. Prominent investigational candidates include obinutuzumab (Roche), ianalumab (Novartis), dapirolizumab pegol (Biogen/UCB), upadacitinib (AbbVie), deucravacitinib (Bristol Myers Squibb), litifilimab (Biogen and Royalty Pharma), and other innovative agents that have the potential to improve disease control while reducing treatment-related toxicity. Aparna Thakur, Project Manager of Forecasting at DelveInsight, said that Oral small molecules such as cenerimod (S1P1 modulator), deucravacitinib (TYK2 inhibitor), and upadacitinib (JAK1 inhibitor) target multiple immune pathways in SLE, reflecting a shift toward oral multi-pathway immune modulation in treatment. In parallel, CAR T-cell therapies are emerging as a potentially transformative approach for patients with refractory SLE by enabling targeted B-cell depletion and immune system reprogramming that could deliver durable, treatment-free remission. Leading programs in this space include rapcabtagene autoleucel (YTB-323), zolacabtagene autoleucel, resecabtagene autoleucel (CABA-201), and obecabtagene autoleucel (obe-cel, AUCATZYL), signaling a potential shift from lifelong immunosuppression toward one-time disease-modifying interventions. As per Thakur, CD19-directed CAR-T therapies, including rapcabtagene autoleucel, zolacabtagene autoleucel, and resecabtagene autoleucel, show strong potential in SLE by inducing deep B-cell depletion and durable remission, though safety risks such as CRS and ICANS require intensive monitoring. Reflecting the growing innovation and expanding therapeutic opportunities in this space, DelveInsight estimates that the SLE market across the leading markets, including the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan, was valued at approximately USD 3 billion in 2025 and is projected to grow at a CAGR of 10.4% through 2036. Below, we highlight 6 emerging late-stage therapies poised to reshape the future of the systemic lupus erythematosus treatment market. Biogen and Royalty Pharma's Litifilimab CLEC4C protein inhibitors Litifilimab (BIIB059) is a humanized IgG1 monoclonal antibody designed to target BDCA2 (Blood Dendritic Cell Antigen 2) and is being developed as a potential therapy for systemic lupus erythematosus (SLE). BDCA2 is a receptor primarily found on plasmacytoid dendritic cells (pDCs), a specialized immune cell population involved in the production of inflammatory mediators. By binding to BDCA2, litifilimab suppresses pDC activation, thereby reducing the release of type I interferons (IFN-I) along with other proinflammatory cytokines and chemokines implicated in SLE pathogenesis. Biogen is currently evaluating litifilimab in two global Phase III clinical studies, TOPAZ-1 (NCT04895241) and TOPAZ-2 (NCT04961567), for patients with SLE, with topline results anticipated by the end of 2026. In October 2025, the company announced that patient enrollment had been completed for both Phase III trials and that the expected data readout timeline had been accelerated to the second half of 2026. Earlier, in February 2025, Biogen entered into a funding agreement with Royalty Pharma, under which it is eligible to receive up to USD 200 million in 2025 and an additional USD 50 million in 2026 to help support the ongoing development of the litifilimab program. Roche's Obinutuzumab (GAZYVA/GAZYVARO) TSLP inhibitor Obinutuzumab is a glycoengineered monoclonal antibody designed to target the CD20 protein expressed on the surface of lymphoma and leukemia cells. As a type II anti-CD20 antibody, it exhibits greater antibody-dependent cellular cytotoxicity and stronger direct cell-killing activity compared with conventional CD20 antibodies. After binding to CD20, obinutuzumab promotes B-cell destruction by engaging immune effector cells, directly triggering intracellular death-signaling pathways, and activating the complement cascade. In Europe, the therapy is marketed under the name GAZYVARO. In February 2026, Roche submitted regulatory applications in the United States and Europe seeking approval of obinutuzumab for the treatment of Systemic Lupus Erythematosus. Subsequently, in April 2026, Roche announced that the FDA had accepted its supplemental Biologics License Application (sBLA) for obinutuzumab in SLE. The filing is based on positive results from the Phase III ALLEGORY study, which showed a statistically significant and clinically meaningful improvement in the primary endpoint. The FDA is expected to issue a decision on the application by December 2026. Discover more about which pipeline drugs could transform systemic lupus erythematosus treatment @ Systemic Lupus Erythematosus Market Size Novartis' Ianalumab BAFF-R inhibitor, ADCC-mediated B-cell depletor Ianalumab, a novel monoclonal antibody developed by Novartis, targets the B-cell Activating Factor Receptor (BAFF-R). It is designed to inhibit BAFF-R signaling while simultaneously promoting B-cell depletion through antibody-dependent cellular cytotoxicity (ADCC). The therapy is currently being evaluated in two Phase III clinical studies for systemic lupus erythematosus (SLE): NCT05639114 (SIRIUS-SLE 1) and NCT05624749 (SIRIUS-SLE 2). According to Novartis' 2026 interim financial report, topline results from the Phase III SIRIUS-SLE 1 and SIRIUS-SLE 2 trials are expected in 2027. Pending positive outcomes, the company plans to submit Ianalumab for regulatory approval in SLE in 2028. Johnson & Johnson's Nipocalimab (IMAAVY) FcRn blockade Nipocalimab is an investigational immunoselective therapy engineered to selectively bind with high affinity to the neonatal Fc receptor (FcRn), blocking its activity and lowering circulating pathogenic IgG antibodies while maintaining essential immune functions. The therapy is being evaluated across three major autoantibody-driven disease areas: rheumatologic disorders, rare autoantibody-mediated conditions, and maternal-fetal diseases, where inhibiting IgG interaction with FcRn in the placenta is expected to reduce the transfer of harmful maternal alloantibodies to the fetus. In March 2026, Johnson & Johnson announced that the U.S. Food and Drug Administration granted Fast Track Designation (FTD) to nipocalimab for the treatment of Systemic Lupus Erythematosus. Explore systemic lupus erythematosus competitors Johnson & Johnson marketed products @ Systemic Lupus Erythematosus Marketed Drugs Idorsia Pharmaceuticals and Viatris' Cenerimod Sphingosine 1-phosphate receptor modulators Cenerimod is a highly selective Sphingosine-1-Phosphate Receptor 1 (S1P1) modulator administered as a once-daily oral tablet. Although the exact cause of systemic lupus erythematosus remains unclear, dysregulated T and B lymphocytes are recognized as central drivers of disease pathogenesis. By selectively targeting the S1P1 receptor, cenerimod is designed to modulate lymphocyte trafficking and reduce immune-mediated inflammation. The therapy is currently being evaluated in two Phase III clinical trials, OPUS-1 (NCT05648500) and OPUS-2 (NCT05672576), for the treatment of SLE. The US FDA has also granted Fast Track Designation (FTD) to cenerimod, underscoring its potential to address an unmet medical need in SLE. In February 2025, Idorsia Pharmaceuticals amended its collaboration agreement with Viatris for the development of cenerimod. Under the revised terms, Idorsia's contribution toward the drug's 2025 development costs was reduced by USD 100 million. In exchange, the company agreed to a USD 250 million reduction in future regulatory and commercial milestone payments while granting Viatris expanded territorial commercialization rights for cenerimod. AbbVie's RINVOQ (upadacitinib) JAK 1 inhibitor Upadacitinib (ABT-494) is a selective inhibitor of Janus kinase 1 (JAK1) that is approved for the treatment of several immune-mediated inflammatory diseases, including ankylosing spondylitis, atopic dermatitis, axial spondyloarthritis, Crohn's disease, giant cell arteritis, psoriatic arthritis, rheumatoid arthritis, and ulcerative colitis. In addition to its approved indications, the therapy is currently under clinical investigation for potential use in alopecia areata, hidradenitis suppurativa (HS), systemic lupus erythematosus (SLE), Takayasu arteritis, and vitiligo. AbbVie's RINVOQ (upadacitinib) continues to be an interesting lupus asset after its Phase 2 SLEek study showed meaningful activity in moderate to severe systemic lupus erythematosus, with the 30 mg monotherapy arm meeting the primary endpoint and achieving steroid-sparing benefit versus placebo. Updated data presented in 2023 also showed durability through 48 weeks, with fewer flares, longer time to first flare, and sustained improvements in disease-activity measures such as SRI-4, BICLA, and LLDAS, while no new safety signals were reported. The key development story is that AbbVie advanced RINVOQ into Phase 3 lupus testing after the positive Phase 2 readout, but it did not move forward with the ABBV-599 combination because elsubrutinib did not add enough efficacy to justify development. Find out more about top SLE CAR-T pipeline assets @ Systemic Lupus Erythematosus Clinical Trials Source: Systemic Lupus Erythematosus Market Report Systemic Lupus Erythematosus Market Insights, Epidemiology, and Market Forecast – 2036 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key SLE companies, including GlaxoSmithKline, AstraZeneca, Genentech (Roche), AbbVie, Bristol Myers Squibb, Novartis, MorphoSys, UCB Pharma, Biogen, Juno Therapeutics, Johnson & Johnson Innovative Medicine, Idorsia Pharmaceuticals, Viatris, Merck, and others. Related Reports Systemic Lupus Erythematosus Clinical Trial Analysis Complement 3 Glomerulopathy Pipeline Insight – 2026 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key SLE companies, including Yake Biotechnology, UCB, Sorrento Therapeutics, SinoMab Bioscience Ltd, Shanghai Junshi Biosciences, Sareum, Sanofi, Roche, Rheos Medicine, Resolve, Provention Bio, Pfizer, Novartis, Neovacs, Merck, Medsenic, Landos Biopharma, Kezar Life Sciences, Kangpu Biopharmaceuticals, Janssen Research & Development, Janssen, InnoCare, ImmuPharma, I-MAB Biopharma, ILTOO, Idorsia Pharmaceuticals, Horizon Therapeutics, Genovax, Exinda Therapeutics, Equillium, Eli Lilly and Company, Eisai, Daiichi Sankyo Company, Corestem, Corbus Pharmaceuticals, Citryll BV, Chipscreen Biosciences, Carna Bioscience, Bristol-Myers Squibb, Brickell Biotech, Boston Pharmaceuticals, Biogen, Athos Therapeutics, Asahi Kasei Pharma, Aria Pharmaceuticals, Antengene Therapeutics, Amgen, Alpine Immune Sciences, Akeso Biopharma, AbbVie, and others. JAK Inhibitors Market JAK Inhibitors Market Size, Target Population, Competitive Landscape & Market Forecast – 2036 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key JAK inhibitors companies, including Incyte Corporation, Aclaris Therapeutics, Sareum, Takeda, AstraZeneca, Ajax Therapeutics, Pfizer, GSK, Dizal Pharmaceutical, Confluence Life Sciences, Celon Pharma, Arcutis Biotherapeutics, Reistone Biopharma, and others. FcRn Inhibitors Market FcRn Inhibitors Market Size, Target Population, Competitive Landscape & Market Forecast – 2036 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key FcRn inhibitors companies, including Immunovant, Viridian Therapeutics, argenx, and others. TSLP Inhibitors Market TSLP Inhibitors Market Size, Target Population, Competitive Landscape & Market Forecast – 2036 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key TSLP inhibitors companies, including Sanofi, Uniquity Bio, Upstream Bio, Keymed Biosciences, Belenos Bioscience, Biosion, Pfizer, and others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 SOURCE DelveInsight Business Research, LLP 21% more press release views with Request a Demo

Phase 3Phase 2Clinical ResultImmunotherapyFast Track

06 Jul 2026

·www.businesswire.com

Aurinia Announces Initiation of PRESERVE, a Study Investigating the Combination of LUPKYNIS and Belimumab, Obinutuzumab or Anifrolumab in Patients with Lupus Nephritis

ROCKVILLE, Md. & EDMONTON, Alberta--(BUSINESS WIRE)--Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) today announced the initiation of PRESERVE, a Phase 4, multicenter study investigating the combination of LUPKYNIS® and belimumab, obinutuzumab or anifrolumab in patients with lupus nephritis (ClinicalTrials.gov). Planned enrollment is approximately 150 patients across approximately 50 sites in the US. The Study’s primary endpoint is the proportion of patients achieving complete renal response (CRR) at 6 months. LUPKYNIS is the only FDA-approved oral therapy for lupus nephritis and the only treatment for lupus nephritis that has shown a statistically significant increase in CRR after 6 months of therapy. Belimumab is a B cell-activating factor (BAFF) inhibitor indicated for the treatment of both systemic lupus erythematosus (SLE) and lupus nephritis. Obinutuzumab is a CD20-directed cytolytic antibody indicated for the treatment of lupus nephritis. Anifrolumab is a type 1 interferon receptor antagonist indicated for the treatment of SLE. “As underscored by the recently published American College of Rheumatology guidelines for the treatment of lupus nephritis, the goal of treatment should be to arrest proteinuria, which is the hallmark sign of ongoing kidney damage, as quickly as possible,” commented Anca Askanase, MD, MPH, Chair of the Department of Medicine and Chief of the Division of Rheumatology at Hospital for Special Surgery and Co-Lead Investigator of PRESERVE. “Unfortunately, even with the newer agents approved in the past few years, the majority of patients do not achieve CRR by 6 months, and many do not achieve CRR even by 12 months.” “There is great mechanistic rationale in combining LUPKYNIS with these biologic agents to improve outcomes,” commented Arvind Madan, MD, Physician and Principal Investigator of the Research Division at Central Florida Kidney Specialists and Co-Lead Investigator of PRESERVE. “LUPKYNIS protects the kidneys by directly stabilizing podocytes and inhibiting T cell activation, belimumab and obinutuzumab inhibit B cell activation, and anifrolumab blocks type 1 interferon signaling. By taking a multitarget therapeutic approach that intervenes in non-redundant biological pathways, each of which independently contribute to nephron loss, there is the potential to stop nephron damage more rapidly in the short term and preserve more kidney function in the long term.” About Aurinia Aurinia is a biopharmaceutical company focused on delivering therapies to people living with autoimmune diseases with high unmet medical needs. In January 2021, the Company introduced LUPKYNIS (voclosporin), the first FDA-approved oral therapy for the treatment of adult patients with active lupus nephritis. Aurinia is also developing aritinercept, a dual inhibitor of B cell-activating factor (BAFF) and a proliferation-inducing ligand (APRIL) for the potential treatment of autoimmune diseases. Forward-Looking Statements This press release contains forward-looking information within the meaning of applicable Canadian securities law and forward-looking statements within the meaning of applicable U.S. securities law. We caution investors that forward-looking statements are based on management’s expectations and assumptions as of the date of this press release and involve substantial risks and uncertainties that could cause the actual outcomes to differ materially from what we currently expect. These risks and uncertainties include, but are not limited to, those associated with the conduct, timing and results of clinical studies and other risks and uncertainties identified in our filings with the U.S. Securities and Exchange Commission. Forward-looking statements in this press release apply only as of the date made, and we undertake no obligation to update or revise any forward-looking statements to reflect subsequent events or circumstances. Additional information related to Aurinia, including a detailed list of the risks and uncertainties affecting Aurinia and its business, can be found in Aurinia’s most recent Annual Report on Form 10-K and its other public available filings available by accessing the Canadian Securities Administrators’ System for Electronic Document Analysis and Retrieval (SEDAR) website at www.sedarplus.ca or the U.S. Securities and Exchange Commission’s Electronic Document Gathering and Retrieval System (EDGAR) website at www.sec.gov/edgar, and on Aurinia’s website at www.auriniapharma.com.

Drug ApprovalPhase 3Phase 2

28 Apr 2026

·www.pharmaceutical-technology.com

FDA approves AstraZeneca’s Saphnelo for SLE

SLE is an autoimmune condition causing symptoms such as joint swelling, rashes, and organ damage. Credit: StanislavSukhin / Shutterstock.com. AstraZeneca has received approval from the US Food and Drug Administration (FDA) for the subcutaneous self-administration of Saphnelo (anifrolumab-fnia) using the Saphnelo Pen autoinjector for systemic lupus erythematosus (SLE). The approval allows adults with SLE on standard therapy to inject Saphnelo themselves. It is supported by results from the Phase III TULIP-SC trial, which demonstrated that subcutaneous Saphnelo significantly reduced SLE disease activity compared to placebo in patients receiving standard care. The safety results observed matched the previously established safety profile for the intravenous formulation of Saphnelo. AstraZeneca biopharmaceuticals executive vice-president Ruud Dobber 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.” SLE is an autoimmune condition where the immune system targets healthy tissues and organs, leading to a complex range of symptoms that can include fatigue, fevers, joint swelling, pain and rashes. Subcutaneous Saphnelo use is already authorised in Japan and the European Union and remains under regulatory review in several other markets. The intravenous route is approved in more than 70 countries. AstraZeneca obtained global rights to Saphnelo in 2004 through an exclusive agreement with biopharmaceutical company Medarex. The co-promotion option for Medarex lapsed when it was acquired by Bristol-Myers Squibb (BMS) in 2009. According to the revised 2025 agreement, AstraZeneca will provide BMS with mid-teens royalties for US sales. Earlier this year, AstraZeneca secured approval in the US for Calquence (acalabrutinib) plus venetoclax as the first all-oral, fixed-duration regimen to treat adults with chronic lymphocytic leukaemia (CLL) and small lymphocytic lymphoma (SLL) in the first-line setting.

Clinical ResultPhase 3Drug ApprovalLicense out/in

100 Deals associated with Anifrolumab-FNIA

External Link

KEGG	Wiki	ATC	Drug Bank
D11082	Anifrolumab-FNIA	L04AA	DB11976

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Lupus Nephritis	Australia	AstraZeneca Pty Ltd.	29 Mar 2022
Lupus Vasculitis, Central Nervous System	Australia	AstraZeneca Pty Ltd.	29 Mar 2022
Systemic Lupus Erythematosus	United States	AstraZeneca AB	30 Jul 2021

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Lupus Erythematosus, Cutaneous	Phase 3	United States	AstraZeneca PLC	29 Jun 2024
Lupus Erythematosus, Cutaneous	Phase 3	China	AstraZeneca PLC	29 Jun 2024
Lupus Erythematosus, Cutaneous	Phase 3	Japan	AstraZeneca PLC	29 Jun 2024
Lupus Erythematosus, Cutaneous	Phase 3	Argentina	AstraZeneca PLC	29 Jun 2024
Lupus Erythematosus, Cutaneous	Phase 3	Australia	AstraZeneca PLC	29 Jun 2024
Lupus Erythematosus, Cutaneous	Phase 3	Austria	AstraZeneca PLC	29 Jun 2024
Lupus Erythematosus, Cutaneous	Phase 3	Belgium	AstraZeneca AB	29 Jun 2024
Lupus Erythematosus, Cutaneous	Phase 3	Brazil	AstraZeneca PLC	29 Jun 2024
Lupus Erythematosus, Cutaneous	Phase 3	Bulgaria	AstraZeneca PLC	29 Jun 2024
Lupus Erythematosus, Cutaneous	Phase 3	Canada	AstraZeneca PLC	29 Jun 2024

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


EULAR2026	Not Applicable	Systemic Lupus Erythematosus	40	Anifrolumab	tmptqsibju(hynwtpkhrr) = vuojpwfgsd yvgyhmwieh (udxzygsfkr ) View more	Positive	11 Jun 2026
EULAR2026	Not Applicable	Systemic Lupus Erythematosus	1,700	Anifrolumab	jkfttsiuov(ihqtraklwm) = xadlghxjwm czwbbmtkhy (ukphlhesrc ) View more	Positive	11 Jun 2026
				Anifrolumab (IS-naïve)	ondxivhkeq(kpbewktzqr) = zhbhnanxoa hrmzulukdg (hgqqesdinc )
EULAR2026	Not Applicable	Systemic Lupus Erythematosus	164	Anifrolumab	hntorowjdp(oditjgifbf) = rahoiccrlg ebgtmhzayw (upnqxgiufb ) View more	Positive	11 Jun 2026
NCT04877691 (TULIP-SC, EULAR2026)	Phase 3	Systemic Lupus Erythematosus	367	-	yloiacfgzn(snfiaroshh) = htakqotwgn uvsywrhqaf (psagcvfrbp ) View more	Positive	11 Jun 2026
				-	yloiacfgzn(snfiaroshh) = geilmbsgwz uvsywrhqaf (psagcvfrbp ) View more
EULAR2026	Not Applicable	Systemic Lupus Erythematosus	19	Anifrolumab (severe haematologic manifestations + Systemic Lupus Erythematosus)	elxycysfhp(dgobjhmqvh) = 1 because developing an adverse event (reactivation of viral B hepatitis), and 2 because of a severe non-hematologic SLE flare (one with renal flare, another with musculoskeletal flare). Only one patient suffered from Herpes Zoster infection, but without leading to ANI discontinuation. mnvxewfuxc (dilqyplvre )	Positive	11 Jun 2026
				Anifrolumab (severe haematologic active patients)
NCT04877691 (TULIP-SC, EULAR2026)	Phase 3	Systemic Lupus Erythematosus	367	ANIFROLUMAB	bfdlshtacc(jaquaevucv) = eacsqnxpqv igtwcakwsa (bxenlvbtnx ) View more	Positive	11 Jun 2026
				Placebo	bfdlshtacc(jaquaevucv) = fstzmpqemz igtwcakwsa (bxenlvbtnx ) View more
EULAR2026	Not Applicable	Systemic Lupus Erythematosus	241	Anifrolumab (Systemic Lupus Erythematosus)	duxqywbtuv(oyvzxhgnyg) = 26 patients discontinued treatment due to primary failure (n=12), secondary failure (n=3), severe infections (n=6), hypotension (n=1), acute anterior uveitis (n=1), autoimmune hemolytic anemia (n=1), thoracic tumor (n=1) and pregnancy desire (n=1). yczbriecfm (gcionnvwro ) View more	Positive	11 Jun 2026
NCT04931563 (AZALEA, EULAR2026)	Phase 3	Systemic Lupus Erythematosus	185	Anifrolumab 300 mg	mlhgprakpw(akflrdfazt) = yajmryoocr vryobfjhkc (xkrupxeqzx ) View more	Positive	11 Jun 2026
				Placebo	mlhgprakpw(akflrdfazt) = cwkeolzdzh vryobfjhkc (xkrupxeqzx ) View more
EULAR2026	Not Applicable	Systemic Lupus Erythematosus	241	Belimumab exposed	vyoszklhpf(cxewrwrszx) = vqwmnesrhn whpwxrwjrm (mtczwepvsw ) View more	Positive	11 Jun 2026
				Belimumab naive	vyoszklhpf(cxewrwrszx) = wqxujtedlc whpwxrwjrm (mtczwepvsw ) View more
NCT05637112 (ASTER, EULAR2026)	Not Applicable	Systemic Lupus Erythematosus	530	Anifrolumab	uhmprpkkni(rraddjwlwj) = nhxbcotcru calzgcbfyx (gpgtcerkmn ) View more	Positive	11 Jun 2026
				Anifrolumab (DORIS remission)	qsupxbmhjy(iulfwbvooo) = nupgreoqms mnjfpqakgg (tsmetwyqwg, 45.9 - 69.4) View more

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