Efgartigimod alfa

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Efgartigimod alfa
Clinical data
Trade namesVyvgart
Other namesARGX-113, efgartigimod alfa-fcab
License data
Routes of
administration		Intravenous
Drug classNeonatal Fc receptor blocker
ATC code
Legal status
Legal status
Identifiers
CAS Number
IUPHAR/BPS
DrugBank
UNII
KEGG
Chemical and physical data
FormulaC2310H3554N602O692S14
Molar mass51280.20 g·mol−1

Efgartigimod alfa, sold under the brand name Vyvgart, is a medication used to treat myasthenia gravis.[3][4] Efgartigimod alfa is a neonatal Fc receptor blocker and is a new class of medication.[4] It is an antibody fragment that binds to the neonatal Fc receptor (FcRn), preventing FcRn from recycling immunoglobulin G (IgG) back into the blood.[4] The medication causes a reduction in overall levels of IgG, including the abnormal acetylcholine receptor (AChR) antibodies that are present in myasthenia gravis.[4] It is also available coformulated with hyaluronidase.[6]

The most common side effects include respiratory tract infections, headache, urinary tract infections, and paresthesia (numbness, tingling).[4][7]

It was approved for medical use in the United States in December 2021,[4][7][8][9] and in the European Union in August 2022.[5] The US Food and Drug Administration considers it to be a first-in-class medication.[10]

Medical uses[edit]

Efgartigimod alfa is indicated for the treatment of generalized myasthenia gravis (gMG) in adults who are anti-acetylcholine receptor (AChR) antibody positive.[4]

History[edit]

The safety and efficacy of efgartigimod alfa were evaluated in a 26-week clinical study of 167 participants with myasthenia gravis who were randomized to receive either efgartigimod alfa or placebo.[4] It was a randomized, double-blind, placebo-controlled trial.[7] The study showed that more participants with myasthenia gravis with antibodies responded to treatment during the first cycle of efgartigimod alfa (68%) compared to those who received placebo (30%) on a measure that assesses the impact of myasthenia gravis on daily function.[4] More participants receiving efgartigimod alfa also demonstrated response on a measure of muscle weakness compared to placebo.[4] The trial was conducted at 56 sites in 15 countries in Belgium, Canada, the Czech Republic, Denmark, France, Georgia, Germany, Hungary, Italy, Japan, the Netherlands, Poland, the Russian Federation, Serbia, and the US.[7]

Efgartigimod alfa is also studied for the treatment of patients with chronic inflammatory demyelinating polyneuropathy (CIDP). The clinical trial known as ADHERE, conducted by Argenx, involved the enrollment of 322 individuals diagnosed with CIDP.[11] In the initial phase of the study, all subjects received weekly injections of Vyvgart. Following a period of 12 weeks, it was observed that 67% of the patients exhibited positive responses to Vyvgart, as evidenced by improvements in their muscle disability scores.[12]

It is also under development for the treatment of primary membranous nephropathy, idiopathic inflammatory myopathy (IIM), anti-neutrophil cytoplasmic antibody-associated vasculitis (ANCA Vasculitis), Graves'' ophthalmopathy, antibody-mediated rejection (AMR), immune-mediated necrotizing myopathy, anti-synthetase syndrome, dermatomyositis, polymyositis, immune thrombocytopenia, primary Sjögren's syndrome, rheumatoid arthritis and pemphigus.[13]

Pharmacodynamics[edit]

Efgartigimod alfa as a drug is an antibody fragment that binds to the neonatal Fc receptor. When this binding happens, the IgG recycling process is blocked. The amount of circulating IgG decreases and therefore prevents the acetylcholine receptors from being degraded by the autoantibodies that are responsible for the myasthenia gravis.[14]

Pharmacokinetics[edit]

The drug is mainly metabolized via proteolytic enzymes.[14][unreliable source?] The termination half-life of Efgartigimod alfa is 80 to 120 hours.[14][unreliable source?]

Side effects[edit]

Side effects of efgartigimod alfa include respiratory tract infections, headache, urinary tract infection, numbness and tingling and muscle pain.[14][unreliable source?]

Society and culture[edit]

Legal status[edit]

The US Food and Drug Administration (FDA) granted the application for efgartigimod alfa fast track and orphan drug designations.[4][15][16][17][10] The FDA granted the approval of Vyvgart to Argenx BV.[4]

In June 2022, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Vyvgart, intended for the treatment of anti‑acetylcholine receptor (AChR) antibody positive generalized myasthenia gravis.[18] The applicant for this medicinal product is Argenx.[18] Efgartigimod alfa was approved for medical use in the European Union in August 2022.[5][19]

Names[edit]

Efgartigimod alfa is the international nonproprietary name (INN).[20]

Marketing and Sales[edit]

Vyvgart brought in $1.2 billion in revenue in 2023.[21]

References[edit]

  1. ^ "Details for: Vyvgart". Health Canada. 6 November 2023. Retrieved 3 March 2024.
  2. ^ "Notice: Multiple additions to the Prescription Drug List (PDL) [2023-12-22]". Health Canada. 22 December 2023. Retrieved 3 January 2024.
  3. ^ a b "Vyvgart- efgartigimod alfa injection". DailyMed. Archived from the original on 25 December 2021. Retrieved 24 December 2021.
  4. ^ a b c d e f g h i j k l m "FDA Approves New Treatment for Myasthenia Gravis". U.S. Food and Drug Administration (FDA) (Press release). 17 December 2021. Archived from the original on 20 December 2021. Retrieved 21 December 2021. Public Domain This article incorporates text from this source, which is in the public domain.
  5. ^ a b c "Vyvgart EPAR". European Medicines Agency (EMA). 20 June 2022. Archived from the original on 28 September 2022. Retrieved 27 September 2022. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  6. ^ "Argenx Announces U.S. Food and Drug Administration Approval of Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) Injection for Subcutaneous Use in Generalized Myasthenia Gravis". Argenx (Press release). 20 June 2023. Retrieved 24 June 2023.
  7. ^ a b c d "Drug Trials Snapshot: Vyvgart". U.S. Food and Drug Administration. 23 May 2023. Retrieved 27 May 2023. Public Domain This article incorporates text from this source, which is in the public domain.
  8. ^ "Argenx Announces U.S. Food and Drug Administration (FDA) Approval of Vyvgart (efgartigimod alfa-fcab) in Generalized Myasthenia Gravis" (Press release). Argenx. 17 December 2021. Archived from the original on 20 December 2021. Retrieved 21 December 2021.
  9. ^ "Argenx Announces U.S. Food and Drug Administration (FDA) Approval of Vyvgart (efgartigimod alfa-fcab) in Generalized Myasthenia Gravis" (Press release). Argenx. 17 December 2021. Archived from the original on 19 December 2021. Retrieved 21 December 2021 – via Business Wire.
  10. ^ a b Advancing Health Through Innovation: New Drug Therapy Approvals 2021 (PDF). U.S. Food and Drug Administration (FDA) (Report). 13 May 2022. Archived from the original on 6 December 2022. Retrieved 22 January 2023. Public Domain This article incorporates text from this source, which is in the public domain.
  11. ^ argenx (3 August 2023). A Phase 2 Trial to Investigate the Efficacy, Safety, and Tolerability of Efgartigimod PH20 SC in Adult Patients With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) (Report). clinicaltrials.gov.
  12. ^ Feuerstein, Adam (17 July 2023). "Argenx antibody drug significantly slows progression of nerve disorder that robs patients of muscle strength". STAT. Retrieved 9 March 2024.
  13. ^ kgi-admin (25 December 2023). "Efgartigimod alfa by Argenx for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP): Likelihood of Approval". Pharmaceutical Technology. Retrieved 9 March 2024.
  14. ^ a b c d "Efgartigimod alfa". Drugbank. Archived from the original on 5 February 2022. Retrieved 19 July 2022.
  15. ^ "Efgartigimod alfa Orphan Drug Designations and Approvals". U.S. Food and Drug Administration. 2 January 2019. Archived from the original on 22 December 2021. Retrieved 21 December 2021.
  16. ^ "Efgartigimod alfa Orphan Drug Designations and Approvals". U.S. Food and Drug Administration. 20 September 2017. Archived from the original on 22 December 2021. Retrieved 21 December 2021.
  17. ^ "Efgartigimod alfa Orphan Drug Designations and Approvals". U.S. Food and Drug Administration (FDA). 11 August 2021. Archived from the original on 8 November 2021. Retrieved 21 December 2021.
  18. ^ a b "Vyvgart: Pending EC decision". European Medicines Agency (EMA). 24 June 2022. Archived from the original on 26 June 2022. Retrieved 26 June 2022. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  19. ^ "Vyvgart Product information". Union Register of medicinal products. 12 December 2022. Retrieved 3 March 2023.
  20. ^ World Health Organization (2017). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 78". WHO Drug Information. 31 (3). hdl:10665/330961.
  21. ^ "STATUS List - Tim Van Hauwermeiren". STAT. Retrieved 9 March 2024.

Public Domain This article incorporates public domain material from the United States Department of Health and Human Services

Further reading[edit]

External links[edit]

  • Clinical trial number NCT03669588 for "An Efficacy and Safety Study of ARGX-113 in Patients With Myasthenia Gravis Who Have Generalized Muscle Weakness (ADAPT)" at ClinicalTrials.gov
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