Efgartigimod alfa

From WikiProjectMed
Jump to navigation Jump to search
Efgartigimod alfa
Names
Trade namesVyvgart
Other namesARGX-113, Efgartigimod alfa-fcab
Clinical data
Drug classNeonatal Fc receptor blocker
Main usesMyasthenia gravis[1]
Side effectsRespiratory tract infections, headache, urinary tract infections[2]
Routes of
use
Intravenous
Typical dose10 mg/kg[1]
External links
AHFS/Drugs.comMonograph
US NLMEfgartigimod alfa
Legal
License data
Legal status
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.[1][2] Specifically it is used for generalized disease that has antibodies against the acetylcholine receptor.[3] It is given by injection into a vein.[3]

Common side effects include respiratory tract infections, headache, and urinary tract infections.[2] Other side effect may include angioedema.[1] It is an antibody fragment that binds to neonatal Fc receptor and prevents it from recycling immunoglobulin G (IgG).[2] This decreases overall levels of IgG, including the abnormal acetylcholine receptor (AChR) antibodies in myasthenia gravis.[2]

Efgartigimod alfa was approved for medical use in the United States in 2021 and Europe in 2022.[2][3] In the United States it costs about 225,000 USD per year as of 2022.[4] As of 2022 it is not commercially available in the United Kingdom.[4]

Medical uses

Efgartigimod alfa is indicated for the treatment of generalized myasthenia gravis (gMG) in adults who are anti-acetylcholine receptor (AChR) antibody positive.[2] With treatment 38% more people improved.[3]

Dosage

It is typically given at a dose of 10 mg/kg to a maximum of 1,200 mg once per week for four weeks.[1]

Side effects

Side effects include respiratory tract infections, headache, urinary tract infection, numbness and tingling and muscle pain.[5]

Pharmacology

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.[5]

Pharmacokinetics

The drug is mainly metabolized via proteolytic enzymes.[5] The termination half-life of efgartigimod alfa is 80 to 120 hours.[5]

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.[2] 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.[2] More participants receiving efgartigimod alfa also demonstrated response on a measure of muscle weakness compared to placebo.[2]

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.[2][6][7][8] The FDA granted the approval of Vyvgart to Argenx BV.[2]

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.[9] The applicant for this medicinal product is Argenx.[9] Efgartigimod alfa was approved for medical use in the European Union in August 2022.[3]

Names

Efgartigimod alfa is the international nonproprietary name (INN).[10]

References

  1. 1.0 1.1 1.2 1.3 1.4 1.5 "Vyvgart- efgartigimod alfa injection". DailyMed. Archived from the original on 25 December 2021. Retrieved 24 December 2021.
  2. 2.00 2.01 2.02 2.03 2.04 2.05 2.06 2.07 2.08 2.09 2.10 2.11 2.12 "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. Public Domain This article incorporates text from this source, which is in the public domain.
  3. 3.0 3.1 3.2 3.3 3.4 3.5 "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.
  4. 4.0 4.1 "Efgartigimod". SPS - Specialist Pharmacy Service. 18 December 2019. Retrieved 23 October 2022.
  5. 5.0 5.1 5.2 5.3 "Efgartigimod alfa". Drugbank. Archived from the original on 5 February 2022. Retrieved 2022-07-19.
  6. "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.
  7. "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.
  8. "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.
  9. 9.0 9.1 "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.
  10. World Health Organization (2017). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 78". WHO Drug Information. 31 (3). hdl:10665/330961.

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

Further reading

External links

Identifiers:
  • "Efgartigimod alfa". Drug Information Portal. U.S. National Library of Medicine. Archived from the original on 2021-12-22. Retrieved 2022-09-28.
  • 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