Английская Википедия:Emapalumab
Шаблон:Short description Шаблон:Use dmy dates Шаблон:Cs1 config Шаблон:Infobox drug
Emapalumab, sold under the brand name Gamifant, is an anti-interferon-gamma (IFNγ) antibody medication used for the treatment of hemophagocytic lymphohistiocytosis (HLH),[1][2][3] which has no cure.[4]
The most common side effects include infections, hypertension, infusion-related reactions, and pyrexia.[1]
The U.S. Food and Drug Administration (FDA) considers it to be a first-in-class medication.[5]
Medical uses
Emapalumab is used to treat primary hemophagocytic lymphohistiocytosis (HLH) with refractory, recurrent or progressive disease or intolerance with conventional HLH therapy.[1]
Adverse effects
In the clinical trials that lead to emapalumab's FDA approval, the most commonly reported adverse effects were infections (56%), high blood pressure (41%), infusion reactions (27%), and fever (24%).[6][7] Serious adverse effects occurred in about half of the subjects studied in the clinical trial that led to its FDA approval.[7]
Pharmacology
Mechanism of action
In the setting of HLH, over-secretion of IFN-γ is thought to contribute to the pathogenesis of the disease.[6] Emapalumab binds and neutralizes IFN-γ, preventing it from inducing pathological effects.[6]
Pharmacokinetics
Like other antibody-based medications, which are made of amino acid chains called polypeptides, emapalumab is broken down into smaller peptides via the body's normal catabolism.[6]
Society and culture
Legal status
The U.S. Food and Drug Administration (FDA) granted orphan drug designations in 2010 and 2020,[8][9] and breakthrough therapy designation in 2016, on the basis of preliminary data from the phase II trial.[10]
In July 2020, and again in November 2020, the European Medicines Agency (EMA) recommended the refusal of the marketing authorization for emapalumab.[11][12]
Research
The research name of emapalumab was NI-0501.[13] A phase II/III trial began in 2013 and is ongoing Шаблон:As of.[14] The trial targets patients under the age of 18 who have failed to improve on conventional treatments.[15] This study was realised in the context of an EU-funded FP7 project, named FIGHT-HLH (306124).Шаблон:Citation needed
References
External links
Шаблон:Monoclonals for immune system Шаблон:Portal bar Шаблон:Authority control
- ↑ 1,0 1,1 1,2 Шаблон:Cite web Шаблон:PD-notice
- ↑ Шаблон:Cite press release
- ↑ Шаблон:Cite journal
- ↑ Шаблон:ClinicalTrialsGov
- ↑ Шаблон:Cite report
- ↑ 6,0 6,1 6,2 6,3 Ошибка цитирования Неверный тег
<ref>; для сносокGamifant FDA labelне указан текст - ↑ 7,0 7,1 Шаблон:Cite web
- ↑ Шаблон:Cite web
- ↑ Шаблон:Cite web
- ↑ Шаблон:Cite web
- ↑ Шаблон:Cite web
- ↑ Шаблон:Cite web
- ↑ Ошибка цитирования Неверный тег
<ref>; для сносокSearchUSANне указан текст - ↑ Шаблон:ClinicalTrialsGov
- ↑ Шаблон:Cite web
