Lanadelumab

Lanadelumab (INN; trade name Takhzyro) is a human monoclonal antibody (class IgG1 kappa)[2] that targets plasma kallikrein (pKal)[3] in order to promote prevention of angioedema in patients with hereditary angioedema.[4][5] In phase 1 clinical trials Lanadelumab was well tolerated and was reported to reduce cleavage of kininogen in the plasma of patients with hereditary angioedema and decrease the number of patients experiencing attacks of angioedema.[3][6][7][8] As of 2017 ongoing trials for Lanadelumab include two phase 3 studies focused on investigating the utility of Lanadelumab in preventing of acute angioedema attacks in hereditary angioedema patients.[9][10]

Lanadelumab
Monoclonal antibody
TypeWhole antibody
SourceHuman
TargetKallikrein
Clinical data
Trade namesTakhzyro
Other nameslanadelumab-flyo
AHFS/Drugs.comMonograph
License data
Pregnancy
category
Routes of
administration		Subcutaneous
ATC code
Legal status
Legal status
  • AU: S4 (Prescription only)
  • US: ℞-only
  • EU: Rx-only
Identifiers
CAS Number
DrugBank
ChemSpider
  • none
UNII
KEGG
Chemical and physical data
FormulaC6468H10016N1728O2012S47
Molar mass145684.18 g·mol−1

This drug was produced by Dyax Corp and currently under development by Shire.[11] Lanadelumab has been designated by the U.S. Food and Drug Administration (FDA) as a breakthrough therapy.[12]

References
  1. "Lanadelumab (Takhzyro) Use During Pregnancy". Drugs.com. 19 September 2018. Retrieved 4 September 2020.
  2. Kenniston JA, Faucette RR, Martik D, Comeau SR, Lindberg AP, Kopacz KJ, et al. (August 2014). "Inhibition of plasma kallikrein by a highly specific active site blocking antibody". The Journal of Biological Chemistry. 289 (34): 23596–608. doi:10.1074/jbc.M114.569061. PMC 4156074. PMID 24970892.
  3. Banerji A, Busse P, Shennak M, Lumry W, Davis-Lorton M, Wedner HJ, et al. (February 2017). "Inhibiting Plasma Kallikrein for Hereditary Angioedema Prophylaxis" (PDF). The New England Journal of Medicine. 376 (8): 717–728. doi:10.1056/NEJMoa1605767. hdl:2434/550555. PMID 28225674. S2CID 54486011.
  4. Statement On A Nonproprietary Name Adopted By The USAN Council - Lanadelumab, American Medical Association.
  5. World Health Organization (2015). "International Nonproprietary Names for Pharmaceutical Substances (INN). Proposed INN: List 114" (PDF). WHO Drug Information. 29 (4).
  6. Chyung Y, Vince B, Iarrobino R, Sexton D, Kenniston J, Faucette R, et al. (October 2014). "A phase 1 study investigating DX-2930 in healthy subjects". Annals of Allergy, Asthma & Immunology. 113 (4): 460–6.e2. doi:10.1016/j.anai.2014.05.028. PMID 24980392.
  7. Clinical trial number NCT01923207 for "A Single Increasing Dose Study to Assess Safety and Tolerability of DX-2930 in Healthy Subjects" at ClinicalTrials.gov
  8. Clinical trial number NCT02093923 for "Double-Blind, Multiple Ascending Dose Study to Assess Safety, Tolerability and Pharmacokinetics of DX-2930 in Hereditary Angioedema (HAE) Subjects" at ClinicalTrials.gov
  9. Clinical trial number NCT02586805 for "Efficacy and Safety Study of DX-2930 to Prevent Acute Angioedema Attacks in Patients With Type I and Type II HAE" at ClinicalTrials.gov
  10. Clinical trial number NCT02741596 for "Long-term Safety and Efficacy Study of DX-2930 to Prevent Acute Angioedema Attacks in Patients With Type I and Type II HAE" at ClinicalTrials.gov
  11. "Lanadelumab - Takeda". Adis Insight. Springer Nature Switzerland AG. Retrieved 2017-03-24.
  12. "Dyax Corp. Receives FDA Breakthrough Therapy Designation for DX-2930 for Prevention of Attacks of Hereditary Angioedema". www.businesswire.com. Retrieved 2017-03-24.
  • "Lanadelumab". Drug Information Portal. U.S. National Library of Medicine.


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