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Nemolizumab

Nemolizumab
Monoclonal antibody
TypeWhole antibody
SourceHumanized
TargetInterleukin-31 receptor A
Clinical data
Trade namesNemluvio
Other namesCIM-331, CD14152, nemolizumab-ilto
AHFS/Drugs.comMonograph
MedlinePlusa624059
License data
Routes of
administration		Subcutaneous injection
ATC code
Legal status
Legal status
Pharmacokinetic data
MetabolismProteolytic enzymes
Identifiers
CAS Number
DrugBank
ChemSpider
  • none
UNII
KEGG

Nemolizumab, sold under the brand name Nemluvio, is a medication used for the treatment of prurigo nodularis.[1] It is a monoclonal antibody that blocks the interleukin-31 receptor A.[1][2]

Nemolizumab was invented by Chugai, who sold an exclusive license for the drug's development and worldwide marketing (except Japan and Taiwan) to Galderma in 2016.[3]

Nemolizumab was approved for medical use in the United States in August 2024.[2][4][5]

Medical uses

Nemolizumab is indicated for the treatment of adults with prurigo nodularis.[1][2]

History

The US Food and Drug Administration (FDA) approved nemolizumab based on evidence from two clinical trials (OLYMPIA 1 and OLYMPIA 2) of 560 participants with prurigo nodularis.[2] The trials were conducted at 132 sites in 16 countries including Austria, Belgium, Canada, Denmark, France, Netherlands, Germany, Hungary, Italy, Poland, South Korea, Spain, Sweden, Switzerland, the United Kingdom, and the United States.[2] The trials included 99 participants inside the United States.[2] Among the 560 enrolled participants, all of them were evaluated for efficacy (Intent-to-Treat population) and 556 participants were evaluated for safety.[2] In both trials, participants with prurigo nodularis were randomized to receive nemolizumab or placebo.[2] Participants weighing less than 90 kilograms (200 lb) in the nemolizumab group received subcutaneous injections of nemolizumab 60 mg at week 0, followed by 30 mg injections every four weeks.[2] Participants weighing 90 kilograms (200 lb) or more in the nemolizumab group received subcutaneous injections of nemolizumab 60 mg at week 0 and every four weeks.[2]

Society and culture

Names

Nemolizumab is the international nonproprietary name.[6]

References

  1. ^ a b c d "Nemluvio- nemolizumab-ilto injection, powder, lyophilized, for solution". DailyMed. 13 August 2024. Retrieved 5 September 2024.
  2. ^ a b c d e f g h i j "Drug Trials Snapshots: Nemluvio". U.S. Food and Drug Administration (FDA). 1 October 2024. Retrieved 31 October 2024. Public Domain This article incorporates text from this source, which is in the public domain.
  3. ^ "Chugai grants exclusive global license for development and marketing of nemolizumab to Galderma". Pharmabiz.com. 22 July 2016.
  4. ^ "Novel Drug Approvals for 2024". U.S. Food and Drug Administration (FDA). 1 October 2024. Retrieved 29 November 2024.
  5. ^ "Galderma Receives U.S. FDA Approval for Nemluvio (nemolizumab) for Adult Patients Living With Prurigo Nodularis" (Press release). Galderma. 13 August 2024. Retrieved 14 August 2024 – via Business Wire.
  6. ^ World Health Organization (2015). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 74". WHO Drug Information. 29 (3). hdl:10665/331070.

Further reading

  • Kwatra SG, Yosipovitch G, Legat FJ, Reich A, Paul C, Simon D, et al. (October 2023). "Phase 3 Trial of Nemolizumab in Patients with Prurigo Nodularis". The New England Journal of Medicine. 389 (17): 1579–1589. doi:10.1056/NEJMoa2301333. PMID 37888917.
  • Clinical trial number NCT04501666 for "Study to Assess the Efficacy and Safety of Nemolizumab (CD14152) in Participants With Prurigo Nodularis (PN)" at ClinicalTrials.gov
  • Clinical trial number NCT04501679 for "A Study to Assess the Efficacy and Safety of Nemolizumab (CD14152) in Participants With Prurigo Nodularis (PN)" at ClinicalTrials.gov


Quelle: https://en.wikipedia.org/wiki/Nemolizumab