Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 103 |
| INN | Anifrolumab |
| Status | Approved |
| Drug code(s) | MEDI-546, MDX-1333 |
| Brand name | Saphnelo |
| mAb sequence source | mAb human |
| General Molecular Category | Naked monospecific |
| Format, general category | Full length Ab |
| Format details | None |
| Isotype (Fc) | IgG1 |
| Light chain isotype | kappa |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | Transgenic mouse (GenPharm/Medarex/BMS transgenic mouse platform) |
| Target(s) | IFNAR1 |
| Indications of clinical studies | Systemic Lupus Erythematosus, Scleroderma |
| Primary therapeutic area | Immune-mediated / inflammatory disorders |
| Most advanced stage of development (global) | Approved EU, US, Japan, Australia |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | December 15, 2008 |
| Start of Phase 2 | January 15, 2012 |
| Start of Phase 3 | June 15, 2015 |
| Date BLA/NDA submitted to FDA | July 22, 2020 |
| Year of first approval (global) | 2021 |
| Date of first US approval | July 30, 2021 |
| INN, US product name | Anifrolumab, anifrolumab-fnia |
| US or EU approved indications | Treatment of adult patients with moderate to severe systemic lupus erythematosus |
| Company | AstraZeneca |
| Licensee/Partner | None |
| Comments about company or candidate | PDUFA date Sep 30 2021. According to AstraZeneca, marketing application for anifrolumab for systemic lupus erythematosus (SLE) were submitted in the US and EU during the third quarter of 2020. Regulatory decisions are expected in the second half of 2021. [AstraZeneca Q3 results] Aug 29, 2019: AstraZeneca today announced that the Phase III TULIP 2 trial for anifrolumab, a potential new medicine for the treatment of systemic lupus erythematosus (SLE), met its primary endpoint, achieving a statistically-significant and clinically-meaningful reduction in disease activity versus placebo, with both arms receiving standard of care. Listed as Phase 3 in AZ pipeline dated July 25, 2019. Fast track designation for SLE. Aug 31, 2018: AstraZeneca and MedImmune, its global biologics research and development arm, announced top-line results from the TULIP 1 Phase III trial for anifrolumab in adult patients with moderate-to-severe systemic lupus erythematosus (SLE). The trial did not meet the primary endpoint of a statistically-significant reduction in disease activity in patients with SLE as measured by the SLE Responder Index 4 (SRI4) at 12 months. Phase 3 NCT02794285 study recruiting; two Phase 3 studies in SLE started in 2015 are active, not recruiting as of Oct 2017. Two Phase 2 studies active not recruiting as of June 2014. Phase 2 study results were positive: Anifrolumab substantially reduced disease activity compared with placebo across multiple clinical end points in the patients with moderate-to-severe SLE (Arthritis Rheumatol. 2017 Feb;69(2):376-386. doi: 10.1002/art.39962.) |
| Full address of company | Cambridge, United Kingdom Europe United Kingdom https://www.astrazeneca.com/our-company/contact-us.html |
L234F, L235E, P331S mutations to decrease effector function. MEDI546, also known as anifrolumab, is an IFNAR1-specific human monoclonal antibody (IgG1/κ) developed to block the type I IFN pathway. Binds to subunit 1 of the type I IFN receptor (IFNAR1), blocking the action of different type I IFNs (IFN-α, IFN-β and IFN-ω).
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |