GY48LS6

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Эмапалумаб + Анакинра (Emapalumab&Anakinra)
Международное непатентованное наименование Эмапалумаб + Анакинра (Emapalumab&Anakinra)
Торговое наименование -
Производитель, страна Swedish Orphan Biovitrum AB, Sweden
Лекарственная форма Emapalumab, solution is 5 mg/mL i.v. Infusion. Аnakinra, solution for injection 150 mg/mL 0.67 mL, prefilled in a single-use syringe with the strength 100 mg.
Механизм действия

Anakinra is a recombinant form of the human IL-Ra, r-metHuIL-1Ra, which is produced by recombinant DNA technology in an E. coli expression system. Therapeutically, anakinra neutralizes the biological activity of IL-1 (IL-1α and IL-1β) by competitively inhibiting its binding to the IL-1RI. , Emapalumab (previously referred to as NI-0501, trade name Gamifant®) is a fully human Immunoglobulin G1 (IgG1) Anti-Interferon gamma (IFNγ) monoclonal antibody that binds to and neutralizes IFNγ.

Публикации COVID-19

Zhou F et al. Clinical course and risk factors for mortality if adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study. Lancet 2020. doi.org/10.1016/S0140-6736(20)30566-3 1.

 

Huang C et al. Clinical features of patients infected with 2019 novel coronavirus in Wuhan. Lancet 2020; 395(10223):497-506.

 

Ruan Q et al. Clinical predictors of mortality due to COVID-19 based on an analysis of data of 150 patients from Wuhan, China. Intensive Care Med. 2020. doi: 10.1007/s00134-020-05991-x.

Клинические исследования
1.
Название протокола A phase 2/3, randomized, open-label, parallel group, 3-arm, multicenter study investigating the efficacy and safety of intravenous administrations of emapalumab, an anti-interferon gamma (antiIFNγ) monoclonal antibody, and anakinra, an interleukin-1(IL-1) receptor antagonist, versus standard of care, in reducing hyper-inflammation and respiratory distress in patients with SARSCoV-2 infection
Дата начала и окончания КИ April 2, 2020 - September 2020
Название организации, проводящей КИ Swedish Orphan Biovitrum
Страны Italy
Фаза II-III
Кол-во пациентов 54