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Anifrolumab

Generic Name
Anifrolumab
Brand Names
Saphnelo
Drug Type
Biotech
CAS Number
1326232-46-5
Unique Ingredient Identifier
38RL9AE51Q
Background

Anifrolumab, or MEDI-546, is a type 1 interferon receptor (IFNAR) inhibiting IgG1κ monoclonal antibody indicated in the treatment of adults with moderate to severe systemic lupus erythematosus. The standard therapy for systemic lupus erythematosus consists of antimalarials like hydroxychloroquine, glucocorticoids like dexamethasone, and disease modifying antirheumatic drugs like methotrexate.

Three monoclonal antibodies (anifrolumab, rontalizumab, and sifalimumab) that target the type 1 interferon pathway entered clinical trials as potential treatments for systemic lupus erythematosus, but so far only anifrolumab has been approved.

The design of early clinical trials of anti-interferon treatments such as anifrolumab, rontalizumab, and sifalimumab have come under criticism. The design of the clinical trials use different definitions of autoantibody positivity, making comparison between trials difficult; all trials involve large portions of patients also using corticosteroids, which may alter patient responses in the experimental and placebo groups; and patient populations were largely homogenous, which may have increased the odds of success of the trial.

Anifrolumab has also been investigated for the treatment of Scleroderma.

Anifrolumab was granted FDA approval on 30 July 2021.

Indication

Anifrolumab is indicated in the treatment of adults with moderate to severe systemic lupus erythematosus.

Associated Conditions
Moderate Systemic Lupus Erythematosus (SLE), Severe Systemic Lupus Erythematosus (SLE)
Clinical Trials
Related News

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• The global lupus nephritis market is projected to grow significantly by 2034, with the United States accounting for over 80% of the current $1.12 billion market share across major regions. • Several innovative therapies are advancing through clinical trials, including CAR-T cell treatments from companies like Allogene Therapeutics, Adicet Bio, and Caribou Biosciences, which received FDA Fast Track designations. • Key pharmaceutical players including Aurinia Pharmaceuticals, AstraZeneca, and Roche are developing treatments such as voclosporin, anifrolumab, and obinutuzumab to address the significant unmet needs in lupus nephritis management.

AstraZeneca's Saphnelo Secures EU Approval for Systemic Lupus Erythematosus Treatment

• AstraZeneca's Saphnelo becomes the first new SLE treatment approved in the EU in over a decade, offering a novel therapeutic option for moderate to severe cases. • The type I interferon receptor antagonist demonstrated superior efficacy in reducing disease activity and oral corticosteroid use across multiple Phase 3 trials. • With approximately 250,000 EU patients affected by SLE, Saphnelo enters the market as a direct competitor to GSK's Benlysta, which achieved $1.2 billion in global sales last year.

Anifrolumab Shows 60% Reduction in Organ Damage Progression in Lupus Patients

• A new study reveals that anifrolumab (Saphnelo) reduces the risk of long-term organ damage progression by approximately 60% in patients with moderate to severe lupus. • The clinical trial, comparing 354 anifrolumab-treated patients against 561 standard-care patients, demonstrated a significant 0.43-point reduction in the organ damage index score. • Monthly IV administration of anifrolumab, a monoclonal antibody targeting type 1 interferon receptors, shows promising results when added to standard lupus treatments.

Gazyva Shows Significant Improvement in Lupus Nephritis Treatment: Phase III REGENCY Trial Results

• Genentech's Phase III REGENCY trial demonstrates that Gazyva plus standard therapy achieved 46.4% complete renal response in lupus nephritis patients compared to 33.1% with standard therapy alone. • The study, published in NEJM, showed clinically meaningful improvements in complement levels and reductions in anti-dsDNA markers, indicating reduced disease activity and inflammation. • Results were consistent across all patient subgroups, including those with Class IV lupus nephritis and higher baseline proteinuria levels, while maintaining Gazyva's established safety profile.

Genentech's Gazyva Shows Positive Phase III Results in Lupus Nephritis Treatment

• Genentech's Gazyva met its primary endpoint in a Phase III REGENCY study, demonstrating statistically significant benefits for lupus nephritis patients. • Patients treated with Gazyva plus standard therapy achieved a higher rate of complete renal response at 76 weeks compared to standard therapy alone. • The study also showed statistically significant improvements in secondary endpoints, including reduced corticosteroid use and improved proteinuric response. • Gazyva targets disease-causing B cells, potentially preventing or delaying progression to end-stage kidney disease in lupus nephritis patients.

UCB and Biogen's Dapirolizumab Pegol Shows Promise in Phase 3 Lupus Trial

• UCB and Biogen's dapirolizumab pegol met the primary endpoint in a Phase 3 trial for moderate-to-severe systemic lupus erythematosus (SLE). • The drug demonstrated significant clinical improvement in disease activity compared to placebo when added to standard of care. • A second Phase 3 trial, PHOENYCS FLY, is planned to further evaluate the efficacy and safety of dapirolizumab pegol in SLE patients. • Dapirolizumab pegol targets the CD40L pathway, offering a novel approach to reduce B cell activation and autoantibody production in SLE.

AstraZeneca's Saphnelo Enters Phase III Trials for Cutaneous Lupus and Inflammatory Myopathies

• AstraZeneca has initiated two new Phase III trials, LAVENDER and JASMINE, to evaluate Saphnelo (anifrolumab) in cutaneous lupus erythematosus (CLE) and idiopathic inflammatory myopathies (IIM), respectively. • The LAVENDER trial will assess Saphnelo's efficacy in reducing skin disease in approximately 460 adults with chronic and/or cutaneous lupus erythematosus. • The JASMINE trial will evaluate the efficacy and safety of subcutaneous Saphnelo in about 240 adults with moderate to severe idiopathic inflammatory myopathies. • These trials reflect AstraZeneca's focus on immune-mediated diseases and the potential of Saphnelo, a type I interferon receptor antagonist, in conditions with high unmet needs.
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