Chemistry:Efgartigimod alfa

From HandWiki
Short description: Medication
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.[2][3] Efgartigimod alfa is a neonatal Fc receptor blocker and is a new class of medication.[3] It is an antibody fragment that binds to the neonatal Fc receptor (FcRn), preventing FcRn from recycling immunoglobulin G (IgG) back into the blood.[3] The medication causes a reduction in overall levels of IgG, including the abnormal acetylcholine receptor (AChR) antibodies that are present in myasthenia gravis.[3] It is also available coformulated with hyaluronidase.[5]

The most common side effects include respiratory tract infections, headache, urinary tract infections, and paresthesia (numbness, tingling).[3][6]

It was approved for medical use in the United States in December 2021,[3][6][7][8] and in the European Union in August 2022.[4] The US Food and Drug Administration considers it to be a first-in-class medication.[9]

Medical uses

Efgartigimod alfa is indicated for the treatment of generalized myasthenia gravis (gMG) in adults who are anti-acetylcholine receptor (AChR) antibody positive.[3]

History

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.[3] It was a randomized, double-blind, placebo-controlled trial.[6] 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.[3] More participants receiving efgartigimod alfa also demonstrated response on a measure of muscle weakness compared to placebo.[3] 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.[6]

Pharmacodynamics

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.[10]

Pharmacokinetics

The drug is mainly metabolized via proteolytic enzymes.[10][unreliable source?] The termination half-life of Efgartigimod alfa is 80 to 120 hours.[10][unreliable source?]

Side effects

Side effects of efgartigimod alfa include respiratory tract infections, headache, urinary tract infection, numbness and tingling and muscle pain.[10][unreliable source?]

Society and culture

Legal status

The U.S. Food and Drug Administration (FDA) granted the application for efgartigimod alfa fast track and orphan drug designations.[3][11][12][13][9] The FDA granted the approval of Vyvgart to Argenx BV.[3]

On 23 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.[14] The applicant for this medicinal product is Argenx.[14] Efgartigimod alfa was approved for medical use in the European Union in August 2022.[4][15]

Names

Efgartigimod alfa is the international nonproprietary name (INN).[16]

References

  1. ↑ "Notice: Multiple additions to the Prescription Drug List (PDL) [2023-12-22"]. 22 December 2023. https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/prescription-drug-list/notices-changes/multiple-additions-2023-12-22.html. 
  2. ↑ 2.0 2.1 "Vyvgart- efgartigimod alfa injection". https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8aefc8e3-26d6-4ff6-aab9-a7542927e084. 
  3. ↑ 3.00 3.01 3.02 3.03 3.04 3.05 3.06 3.07 3.08 3.09 3.10 3.11 3.12 "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. This article incorporates text from this source, which is in the public domain.
  4. ↑ 4.0 4.1 4.2 "Vyvgart EPAR". 20 June 2022. https://www.ema.europa.eu/en/medicines/human/EPAR/vyvgart.  Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  5. ↑ "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.
  6. ↑ 6.0 6.1 6.2 6.3 "Drug Trials Snapshot: Vyvgart". 23 May 2023. https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshot-vyvgart.  This article incorporates text from this source, which is in the public domain.
  7. ↑ "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.
  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 19 December 2021. Retrieved 21 December 2021 – via Business Wire.
  9. ↑ 9.0 9.1 (PDF) Advancing Health Through Innovation: New Drug Therapy Approvals 2021 (Report). 13 May 2022. https://www.fda.gov/media/155227/download. Retrieved 22 January 2023.  This article incorporates text from this source, which is in the public domain.
  10. ↑ 10.0 10.1 10.2 10.3 "Efgartigimod alfa". https://go.drugbank.com/drugs/DB15270. 
  11. ↑ "Efgartigimod alfa Orphan Drug Designations and Approvals". 2 January 2019. https://www.accessdata.fda.gov/scripts/opdlisting/oopd/detailedIndex.cfm?cfgridkey=633218. 
  12. ↑ "Efgartigimod alfa Orphan Drug Designations and Approvals". 20 September 2017. https://www.accessdata.fda.gov/scripts/opdlisting/oopd/detailedIndex.cfm?cfgridkey=527316. 
  13. ↑ "Efgartigimod alfa Orphan Drug Designations and Approvals". 11 August 2021. https://www.accessdata.fda.gov/scripts/opdlisting/oopd/detailedIndex.cfm?cfgridkey=851421. 
  14. ↑ 14.0 14.1 "Vyvgart: Pending EC decision". 24 June 2022. https://www.ema.europa.eu/en/medicines/human/summaries-opinion/vyvgart.  Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  15. ↑ "Vyvgart Product information". 12 December 2022. https://ec.europa.eu/health/documents/community-register/html/h1674.htm. 
  16. ↑ "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 78". WHO Drug Information 31 (3). 2017. 

 This article incorporates public domain material from the United States Department of Health and Human Services website https://www.fda.gov/.

Further reading

  • "Safety, efficacy, and tolerability of efgartigimod in patients with generalised myasthenia gravis (ADAPT): a multicentre, randomised, placebo-controlled, phase 3 trial". Lancet Neurol 20 (7): 526–536. July 2021. doi:10.1016/S1474-4422(21)00159-9. PMID 34146511. 

External links

  • 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



Retrieved from "https://handwiki.org/wiki/index.php?title=Chemistry:Efgartigimod_alfa&oldid=3334141"