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Xinhua | An sabunta: 11/11/2020 09:20

FILE PHOTO: An nuna tambarin Eli Lilly a ɗaya daga cikin ofisoshin kamfanin a San Diego, California, US, Satumba 17, 2020. [Hoto/Agencies]
WASHINGTON - Hukumar Kula da Abinci da Magunguna ta Amurka ta ba da izinin amfani da gaggawa (EUA) ga likitan Ba'amurke Eli Lilly's monoclonal antibody therapy don kula da COVID-19 mai sauƙi zuwa matsakaici a cikin manya da marasa lafiya na yara.

An ba da izinin maganin, bamlanivimabmasu cutar COVID-19wadanda ke da shekaru 12 da haihuwa suna yin nauyi aƙalla kilo 40, kuma waɗanda ke cikin haɗarin ci gaba zuwa matsananciyar COVID-19 da (ko) asibiti, a cewar sanarwar FDA ranar Litinin.

Wannan ya haɗa da waɗanda shekarunsu suka kai 65 ko sama da haka, ko waɗanda ke da wasu yanayi na rashin lafiya.

Monoclonal antibodies sunadaran da aka yi a dakin gwaje-gwaje waɗanda ke yin kwaikwayon ikon tsarin rigakafi don yaƙar antigens masu cutarwa kamar ƙwayoyin cuta. Bamlanivimab wani maganin rigakafi ne na monoclonal wanda aka keɓe musamman akan furotin mai karu na SARS-CoV-2, wanda aka ƙera don toshe haɗin ƙwayar cuta da shiga cikin ƙwayoyin ɗan adam.

Yayin da ake ci gaba da kimanta aminci da ingancin wannan maganin na binciken, an nuna bamlanivimab a cikin gwaje-gwajen asibiti don rage ziyarar asibiti da ke da alaƙa da COVID-19 ko ɗakin gaggawa (ER) a cikin marasa lafiya da ke cikin haɗarin ci gaba da cuta a cikin kwanaki 28 bayan jiyya idan aka kwatanta. zuwa placebo, in ji FDA.

Bayanan da ke tallafawa EUA don bamlanivimab sun dogara ne akan bincike na wucin gadi daga wani lokaci na biyu bazuwar, makafi biyu, gwajin asibiti da aka sarrafa a cikin 465 manya marasa asibiti tare da alamun COVID-19 masu sauƙi zuwa matsakaici.

Daga cikin wadannan marasa lafiya, 101 sun sami kashi 700-milligram na bamlanivimab, 107 sun karɓi kashi 2,800-milligram, 101 sun karɓi kashi 7,000-milligram kuma 156 sun karɓi placebo a cikin kwanaki uku da samun samfurin asibiti don tabbataccen SARS-CoV- na farko. 2 gwajin hoto.

Ga marasa lafiya da ke da babban haɗari don ci gaba da cututtuka, asibitoci da wuraren gaggawa (ER) sun faru a cikin kashi 3 cikin dari na marasa lafiya na bamlanivimab a matsakaici idan aka kwatanta da 10 bisa dari a cikin marasa lafiya.

Abubuwan da ke tattare da kwayar cutar hoto da kuma raguwa a asibitoci da kuma ziyarar ER, da kuma a kan aminci, sun kasance daidai a cikin marasa lafiya da ke karɓar kowane nau'i na uku na bamlanivimab, bisa ga FDA.

EUA ta ba da damar rarraba bamlanivimab kuma a gudanar da shi azaman kashi ɗaya cikin jini ta ma'aikatan kiwon lafiya.

"Izinin gaggawa na FDA na bamlanivimab yana ba da kwararrun likitocin kiwon lafiya a kan gaba na wannan annoba tare da wani yuwuwar kayan aiki don kula da marasa lafiyar COVID-19," in ji Patrizia Cavazzoni, darektan riko na Cibiyar Nazarin Magunguna da Magunguna ta FDA. "Za mu ci gaba da kimanta sabbin bayanai kan aminci da ingancin bamlanivimab yayin da suke samuwa."

Dangane da nazarin jimillar shaidar kimiyya da ke akwai, FDA ta ƙaddara cewa yana da kyau a yarda cewa bamlanivimab na iya yin tasiri a cikin kula da marasa lafiya marasa asibiti tare da COVID-19 mai sauƙi ko matsakaici. Kuma, lokacin da aka yi amfani da shi don kula da COVID-19 don yawan jama'a da aka ba da izini, sanannun da fa'idodin fa'idodin sun zarce sananne da haɗarin haɗarin maganin, a cewar FDA.

Abubuwan da za su iya haifar da bamlanivimab sun haɗa da anaphylaxis da halayen da ke da alaƙa da jiko, tashin zuciya, gudawa, tashin hankali, ciwon kai, ƙaiƙayi da amai, a cewar hukumar.

EUA ta zo ne yayin da Amurka ta zarce miliyan 10 na COVID-19 a ranar Litinin, kwanaki 10 kacal bayan bullar miliyan 9. Matsakaicin adadin kwanan nan na sabbin cututtukan yau da kullun ya wuce 100,000, kuma masana kiwon lafiyar jama'a sun yi gargadin cewa kasar na shiga cikin mawuyacin hali na annobar.