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

HOTON FILE: An nuna tambarin Eli Lilly a ɗaya daga cikin ofisoshin kamfanin da ke San Diego, California, Amurka, Satumba 17, 2020. [Hoto/Hukumomin]
WASHINGTON — Hukumar Abinci da Magunguna ta Amurka ta bayar da izinin amfani da gaggawa (EUA) ga kamfanin kera magunguna na Amurka Eli Lilly don maganin rigakafin ƙwayoyin cuta mai sauƙi zuwa matsakaici na COVID-19 ga manya da yara.

An ba da izinin maganin, bamlanivimab, donMarasa lafiya na COVID-19waɗanda shekarunsu suka kai 12 zuwa sama suna da nauyin akalla kilogiram 40, kuma suna cikin haɗarin kamuwa da cutar COVID-19 mai tsanani da (ko) kamuwa da cutar a asibiti, a cewar wata sanarwa da FDA ta fitar a ranar Litinin.

Wannan ya haɗa da waɗanda suka kai shekaru 65 ko sama da haka, ko kuma waɗanda ke da wasu cututtuka na yau da kullun.

Kwayoyin rigakafi na monoclonal sunadarai ne da aka yi a dakin gwaje-gwaje waɗanda ke kwaikwayon ikon tsarin garkuwar jiki na yaƙi da ƙwayoyin cuta masu cutarwa kamar ƙwayoyin cuta. Bamlanivimab wani ƙwayoyin rigakafi ne na monoclonal wanda aka yi shi musamman don yaƙar furotin mai ƙarfi na SARS-CoV-2, wanda aka ƙera don toshe hanyar haɗin kwayar cutar da shiga cikin ƙwayoyin halittar ɗan adam.

Duk da cewa ana ci gaba da tantance aminci da ingancin wannan maganin bincike, an nuna bamlanivimab a gwaje-gwajen asibiti don rage ziyarar asibiti ko ɗakin gaggawa (ER) da ke da alaƙa da COVID-19 ga marasa lafiya da ke cikin haɗarin kamuwa da cutar cikin kwanaki 28 bayan magani idan aka kwatanta da placebo, in ji FDA.

Bayanan da ke tallafawa EUA don bamlanivimab sun dogara ne akan wani bincike na wucin gadi daga wani gwaji na asibiti na mataki na biyu wanda ba a tantance ba, wanda aka yi masa makanta biyu, wanda aka sarrafa shi ta hanyar placebo a cikin manya 465 waɗanda ba sa asibiti tare da alamun COVID-19 masu sauƙi zuwa matsakaici.

Daga cikin waɗannan marasa lafiya, 101 sun sami maganin bamlanivimab mai nauyin milligram 700, 107 sun sami maganin milligram 2,800, 101 sun sami maganin milligram 7,000, sannan 156 sun sami maganin placebo cikin kwana uku bayan samun samfurin asibiti don gwajin kwayar cutar SARS-CoV-2 na farko mai inganci.

Ga marasa lafiya da ke cikin haɗarin kamuwa da cutar, an kwantar da su a asibiti da kuma ziyartar ɗakin gaggawa (ER) a matsakaicin kashi 3 cikin ɗari na marasa lafiya da aka yi wa magani da bamlanivimab idan aka kwatanta da kashi 10 cikin ɗari na marasa lafiya da aka yi wa magani da placebo.

A cewar FDA, tasirin da cutar ke yi kan yawan ƙwayoyin cuta da kuma rage yawan zuwa asibiti da kuma ziyartar marasa lafiya, da kuma aminci, iri ɗaya ne a cikin marasa lafiya da suka karɓi kowace ɗaya daga cikin allurai uku na bamlanivimab.

EUA ta ba da damar a rarraba bamlanivimab kuma a ba shi magani ɗaya ta hanyar jijiya ta hanyar masu ba da lafiya.

"Izinin gaggawa na bamlanivimab na FDA ya bai wa kwararrun masana kiwon lafiya a sahun gaba na wannan annoba wata hanya mai yuwuwa wajen magance marasa lafiya na COVID-19," in ji Patrizia Cavazzoni, mukaddashin darakta na Cibiyar Kimanta Magunguna da Bincike ta FDA. "Za mu ci gaba da tantance sabbin bayanai kan aminci da ingancin bamlanivimab yayin da suke samuwa."

Dangane da bitar cikakken shaidar kimiyya da ake da ita, FDA ta gano cewa abu ne mai kyau a yi imani da cewa bamlanivimab na iya yin tasiri wajen kula da marasa lafiya marasa asibiti da ke fama da COVID-19 mai sauƙi ko matsakaici. Kuma, idan aka yi amfani da shi don magance COVID-19 ga mutanen da aka ba da izini, fa'idodin da aka sani da yuwuwar sun fi haɗarin da aka sani da yuwuwar maganin, a cewar FDA.

A cewar hukumar, illolin da bamlanivimab zai iya haifarwa sun hada da rashin lafiyar jiki da kuma yadda ake amfani da shi wajen hada maganin, tashin zuciya, gudawa, jiri, ciwon kai, kaikayi da amai.

Tarayyar Turai (EUA) ta zo ne a daidai lokacin da Amurka ta zarce mutane miliyan 10 da suka kamu da cutar COVID-19 a ranar Litinin, kwanaki 10 kacal bayan ta kai miliyan 9. Matsakaicin adadin sabbin kamuwa da cutar a kullum ya wuce 100,000, kuma kwararrun masana lafiyar jama'a sun yi gargadin cewa kasar na shiga mawuyacin hali a wannan annoba.