Bamlanivimab
bamlanivimab | |
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Kódy | |
Číslo CAS | 2423943-37-5 |
Některá data mohou pocházet z datové položky. |
Bamlanivimab (INN,[1] s kódovým jménem LY-CoV555) je monoklonální protilátka, vyvinutá společnostmi AbCellera Biologics a Eli Lilly jako lék na covid-19.[2]
Léčivo získalo dočasnou autorizaci (emergency use authorization – EUA) od amerického Úřadu pro kontrolu potravin a léčiv (Food and Drug Administration – FDA) v listopadu 2020,[3][4][5] a americká vláda následně zakoupila 950 000 dávek.[6] V dubnu 2021 však byla dočasná autorizace EUA na žádost výrobce (Eli Lilly) zrušena.[7] Nově bude bamlanivimab distribuován a používán již pouze v kombinaci s podobnou látkou etesevimab. Důvodem je klesající účinnost samotného bamlanivimabu proti novým mutacím a variantám viru, proti nimž lépe zabírá zmíněná kombinace léčiv.[8][9][10]
Léčivo je monoklonální protilátkou (mAb) imunoglobulinu G (IgG1) zaměřenou proti hrotovému proteinu viru SARS-CoV-2.[11] Cílem je blokování připojení viru a jeho vstupu do lidské buňky, čímž je virus neutralizován, a tím pomoci s prevencí a léčením covidu-19.[2]
Kombinace bamlanivimab/etesevimab získala autorizaci EUA od amerického Úřadu pro kontrolu potravin a léčiv.[12][13][14]
Reference
V tomto článku byl použit překlad textu z článku Bamlanivimab na anglické Wikipedii.
- ↑ World Health Organization. International Nonproprietary Names for Pharmaceutical Substances (INN). Proposed INN: List 124 – COVID-19 (special edition). WHO Drug Information. 2020, s. 645–6. Dostupné online [cit. 23 November 2020]. (anglicky)
- ↑ a b Eli Lilly and Company: Lilly announces agreement with U.S. government to supply 300,000 vials of investigational neutralizing antibody bamlanivimab (LY-CoV555) in an effort to fight COVID-19, tisková zpráva, [cit. 2021-11-03], Dostupné on-line.
- ↑ Fact Sheet For Health Care Providers Emergency Use Authorization (EUA) Of Bamlanivimab [online]. U.S. Food and Drug Administration (FDA) [cit. 2021-03-18]. Dostupné online. (anglicky)
- ↑ Emergency Use Authorization (EUA) for the Treatment of COVID-19 [online]. Eli Lilly and Company, 9 November 2020 [cit. 2021-03-18]. Dostupné online. (anglicky)
- ↑ http://pi.lilly.com/eua/bamlanivimab-eua-fda-authorization-letter.pdf
- ↑ Eli Lilly and Company: Lilly announces 650,000 additional doses of neutralizing antibody bamlanivimab (LY-CoV555) purchased by U.S. government to treat COVID-19, tisková zpráva, [cit. 2021-11-03], Dostupné on-line.
- ↑ U.S. Food and Drug Administration (FDA): Coronavirus (COVID-19) Update: FDA Revokes Emergency Use Authorization for Monoclonal Antibody Bamlanivimab, tisková zpráva, [cit. 2021-11-03], Dostupné on-line.
- ↑ COMMISSIONER, Office of the. Coronavirus (COVID-19) Update: FDA Revokes Emergency Use Authorization for Monoclonal Antibody Bamlanivimab. FDA [online]. 2021-04-19 [cit. 2021-04-23]. Dostupné online. (anglicky)
- ↑ Lilly requests revocation of emergency use authorization for bamlanivimab alone to complete transition to bamlanivimab and etesevimab together for treatment of COVID-19 in the U.S. | Eli Lilly and Company. investor.lilly.com [online]. [cit. 2021-04-23]. Dostupné online. (anglicky)
- ↑ COMPANY, Eli Lilly and. Lilly requests revocation of emergency use authorization for bamlanivimab alone to complete transition to bamlanivimab and etesevimab together for treatment of COVID-19 in the U.S.. www.prnewswire.com [online]. [cit. 2021-04-23]. Dostupné online. (anglicky)
- ↑ Lilly provides comprehensive update on progress of SARS-CoV-2 neutralizing antibody programs [online]. Eli Lilly and Company, 7 October 2020 [cit. 2020-10-26]. Dostupné online. (anglicky)
- ↑ Fact Sheet For Health Care Providers Emergency Use Authorization (EUA) Of Bamlanivimab and Etesevimab [online]. U.S. Food and Drug Administration (FDA) [cit. 2021-03-18]. Dostupné online. (anglicky)
- ↑ Bamlanivimab and etesevimab EUA [online]. Eli Lilly and Company, 9 February 2021 [cit. 2021-03-18]. Dostupné online. (anglicky)
- ↑ http://pi.lilly.com/eua/bam-and-ete-eua-fda-authorization-letter.pdf
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