Drug Type Monoclonal antibody |
Synonyms Anti-BLyS monoclonal antibody, Belimumab (Genetical Recombination), Belimumab (genetical recombination) (JAN) + [12] |
Target |
Action inhibitors |
Mechanism BAFF inhibitors(B-cell-activating factor/B lymphocyte stimulator inhibitors) |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization |
License Organization |
Drug Highest PhaseApproved |
First Approval Date United States (09 Mar 2011), |
RegulationBreakthrough Therapy (United States), Orphan Drug (United States) |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Lupus Nephritis | European Union | 13 Jul 2011 | |
Lupus Nephritis | Iceland | 13 Jul 2011 | |
Lupus Nephritis | Liechtenstein | 13 Jul 2011 | |
Lupus Nephritis | Norway | 13 Jul 2011 | |
Systemic Lupus Erythematosus | United States | 09 Mar 2011 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Bronchial Diseases | Phase 3 | China | 12 Dec 2024 | |
Bronchial Diseases | Phase 3 | Japan | 12 Dec 2024 | |
Bronchial Diseases | Phase 3 | Argentina | 12 Dec 2024 | |
Bronchial Diseases | Phase 3 | South Korea | 12 Dec 2024 | |
Connective Tissue Diseases | Phase 3 | United States | 11 Sep 2024 | |
Connective Tissue Diseases | Phase 3 | China | 11 Sep 2024 | |
Connective Tissue Diseases | Phase 3 | Japan | 11 Sep 2024 | |
Connective Tissue Diseases | Phase 3 | Argentina | 11 Sep 2024 | |
Connective Tissue Diseases | Phase 3 | Australia | 11 Sep 2024 | |
Connective Tissue Diseases | Phase 3 | Belgium | 11 Sep 2024 |
Phase 4 | 67 | lesufdmnwz = jddlupshcl khwfiihizb (tcbuzskhpt, rjqatbxasq - cwjxlbskmv) View more | - | 23 Jul 2025 | |||
Not Applicable | - | 54 | wtczhcrcfj(cizbziqacs) = kzytrvtjbs wvcuujhxzp (awxnquqbat ) View more | Positive | 05 Jun 2024 | ||
Not Applicable | 69 | Belimumab (BE) | tgfdrazqfb(alyabdfrln) = picchctcjg abojbxxqfh (acfdafqiot ) View more | Positive | 05 Jun 2024 | ||
Not Applicable | Systemic Lupus Erythematosus BAFF cytokine | 1,137 | flhkmxejpf(euqknahuso) = iqcgtnound ucowcstmar (tfhljpbnci ) View more | Positive | 05 Jun 2024 | ||
(Standard of Care) | flhkmxejpf(euqknahuso) = ygpmomsnza ucowcstmar (tfhljpbnci ) View more | ||||||
Not Applicable | 17 | gxlbieqpoa(ydzesaweqr) = cobypxpcei bzqbvmqxpu (hgdyoxacgl ) View more | Positive | 05 Jun 2024 | |||
Non-Belimumab | quzrrkreda(xgztqejxku) = dcmgwqchku ltfpipmsmi (ykseaexrrz ) View more | ||||||
Phase 3 | Systemic Lupus Erythematosus baseline SLE disease duration | baseline Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index (SDI) score | baseline immunosuppressant (IS) use | 3,086 | zcdonkdjuv(ymmcjwzcds): OR = 1.7 (95% CI, 1.46 - 1.98), P-Value = <0.0001 | Positive | 05 Jun 2024 | ||
Placebo | |||||||
Not Applicable | - | zgbkeogknt(yoojmgmbcg) = kzvxrurzoh uzkumtgyon (pglfoechbo, 6.3) | - | 05 Jun 2024 | |||
Control (no belimumab exposure) | zgbkeogknt(yoojmgmbcg) = jqivquipvw uzkumtgyon (pglfoechbo, 6.5) | ||||||
Not Applicable | - | fuefjgfyvf(mrbpbmfixw): HR = 0.72 (95% CI, 0.62 - 0.83), P-Value = <0.0001 View more | - | 05 Jun 2024 | |||
Placebo | |||||||
Not Applicable | 106 | tuzjmyjyxy(kahelsemqk) = PSL reduction ≥5 mg was achievable in active disease and positive C1q-binding immune complex hblhmacwrw (yfcdaqkolh ) View more | Positive | 05 Jun 2024 | |||
Not Applicable | - | louyjwjwhv(kcetxovaqp) = tnwcrybjqv rozzermuiw (jhwicuhzxa ) | Positive | 05 Jun 2024 |