Digital Features for this AdisInsight Report can be found at https://doi.org/10.6084/m9.figshare.19067744. |
A neonatal Fc receptor antagonist is being developed by argenx for the treatment of autoimmune diseases including myasthenia gravis. |
Received its first approval on 17 December 2021 in the USA. |
Approved for use in the treatment of generalized myasthenia gravis in adults who are anti-AChR antibody positive. |
1 Introduction
1.1 Company Agreements
2 Scientific Summary
2.1 Pharmacodynamics
Alternative names | ARGX-113; Efgartigimod–argenx; Efgartigimod alfa-fcab–argenx; efgartigimod PH20; efgartigimod PH20 SC; Vyvgart |
Class | Anti-inflammatories; immunoglobulin Fc fragments; monoclonal antibodies |
Mechanism of action | Neonatal Fc receptor antagonist |
Route of administration | Intravenous; subcutaneous |
Pharmacodynamics | A humanized IgG1 Fc fragment that binds to the neonatal Fc receptor and blocks its interaction with IgG, thereby reducing IgG levels |
Pharmacokinetics | Intravenous formulation displays linear pharmacokinetics and drug exposure increases proportionally after doses up to 50 mg/kg, volume of distribution 15–20 L and terminal half-life 80–120 h; SC formulation has comparable half-life to that of IV formulation with a bioavailability of ≈ 50% |
Most frequent adverse events | Headache, upper respiratory tract infection, urinary tract infection |
ATC codes | |
WHO ATC code | L04A-A58 (efgartigimod alfa) |
EphMRA ATC code | L4 (Immunosuppressants) |
Chemical name | Immunoglobulin G1, anti-(fcrn receptor) (human monoclonal ARGX-113 fc fragment) |
Drug(s) | Indication | Phase | Status | Location(s) | Identifier |
---|---|---|---|---|---|
Efgartigimod (IV), placebo | Myasthenia gravis in adults | III | Completed | Multinational | NCT03669588, EudraCT2018-002132-25, JapicCTI195083, ARGX113-1704; ADAPT |
Efgartigimod (IV) | Myasthenia gravis in adults | III | Ongoing | Multinational | NCT03770403, EudraCT2018-002133-37, JapicCTI205144, ARGX113-1705, ADATPT+ |
Efgartigimod (IV) and (SC) | Myasthenia gravis in adults | III | Ongoing | Multinational | NCT04735432l, EudtaCT2020-004085-19, ARGX-113-2001, ADAPTsc |
Efgartigimod (IV) | Myasthenia gravis in adults | II/III | Recruiting | Multinational | NCT04980495, EudraCT2021-002504-12, ARGX113-2003, ADAPT NXT |
Efgartigimod (IV) | Myasthenia gravis in children | II/III | Recruiting | Multinational | NCT04833894, EudraCT2020-005841-18, ARGX113-2006, P097/2020, ADAPT JR |
Efgartigimod (IV), placebo | Myasthenia gravis in adults | II | Completed | Multinational | NCT02965573, EudraCT2016-002938-73, ARGX113-1602 |
Efgartigimod (SC), placebo | Pemphigus in adults | III | Recruiting | Multinational | NCT04598451, EudraCT2020-002915-23, ARGX113-1904, ADDRESS |
Efgartigimod (SC), placebo | Pemphigus in adults | III | Recruiting | Multinational | NCT04598477, EudraCT2020-002917-16, ARGX113-1905, ADDRESS+ |
Efgartigimod (IV) | Pemphigus in adults | II | Completed | Multinational | NCT03334058, EudraCT2017-002333-40, ARGX113-1701 |
Efgartigimod (IV), placebo | ITP in adults | III | Ongoing | Multinational | NCT04188379, EudraCT2019-002100-41, JapicCTI205112, ARGX113-1801, ADVANCE |
Efgartigimod (IV) | ITP in adults | III | Recruiting | Multinational | NCT04225156, EudraCT2019-002101-21, JapicCTI205113, ARGX113-1803, ADVANCE+ |
Efgartigimod (SC), placebo | ITP in adults | III | Recruiting | Multinational | NCT04687072, EudraCT2020-004032-21, ARGX113-2004,ADVANCE SC |
Efgartigimod (SC) | ITP in adults | III | Recruiting | Multinational | NCT04812925, EudraCT2020-004033-20, ARGX113-2005, ADVANCE SC+ |
Efgartigimod (IV), placebo | ITP in adults | II | Completed | Multinational | NCT03102593, EudraCT2016-003038-26, ARGX113-1603 |
Efgartigimod (SC), placebo | CIDP in adults | II | Recruiting | Multinational | NCT04281472, EudraCT2020-002915-23, ARGX113-1904, ADHERE |
Efgartigimod (SC) | CIDP in adults | II | Recruiting | Multinational | NCT04280718, EudraCT2019-003107-35, ARGX113-1902, ADHERE+ |