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Xinhua | Yakagadziridzwa: 2020-11-11 09:20

MUFANANIDZO WEFAYERO: Chiratidzo cheEli Lilly chinoratidzwa pane imwe yemahofisi ekambani muSan Diego, California, US, Gunyana 17, 2020. [Mufananidzo/Masangano]
WASHINGTON — US Food and Drug Administration yapa mvumo yekushandisa emergency (EUA) yemugadziri wemishonga wekuAmerica anonzi Eli Lilly's monoclonal antibody therapy yekurapa COVID-19 iri pakati nepakati muvarwere vakuru nevana.

Mushonga uyu, bamlanivimab, unobvumidzwa kushandiswaVarwere veCOVID-19avo vane makore gumi nemaviri zvichikwira uye vanorema makirogiramu makumi mana, uye vari panjodzi huru yekupinda muCOVID-19 uye (kana) kugara muchipatara, sekureva kweFDA neMuvhuro.

Izvi zvinosanganisira avo vane makore makumi matanhatu nemashanu zvichikwira, kana vane mamwe matambudziko ehutano asingaperi.

Ma antibodies eMonoclonal mapuroteni akagadzirwa murabhoritari anotevedzera kugona kwemasoja emuviri kurwisa maantigen anokuvadza akadai semavhairasi. Bamlanivimab iantibody yemonoclonal yakanyatsonangana neprotein yeSARS-CoV-2, yakagadzirirwa kudzivirira kubatana kwehutachiona uye kupinda mumasero evanhu.

Kunyange hazvo kuchengetedzeka uye kushanda kwekurapa uku kwekuongorora kuchiramba kuchiongororwa, bamlanivimab yakaratidzwa mukuyedzwa kwekiriniki kuderedza kushanya kwevarwere vari panjodzi huru yekukura kwechirwere mukati memazuva makumi maviri nemasere mushure mekurapwa kana zvichienzaniswa ne placebo, yakadaro FDA.

Ruzivo runotsigira EUA yebamlanivimab rwakavakirwa paongororo yechinguvana kubva muongororo yekiriniki yechikamu chechipiri isina kurongeka, isina kupofumadzwa kaviri, inodzorwa neplacebo muvanhu vakuru 465 vasiri muchipatara vane zviratidzo zveCOVID-19 zvishoma kusvika pakati nepakati.

Pavarwere ava, 101 vakapihwa mushonga we bamlanivimab we 700-milligram, 107 vakapihwa mushonga we 2,800-milligram, 101 vakapihwa mushonga we 7,000-milligram uye 156 vakapihwa mushonga we placebo mukati memazuva matatu mushure mekuongororwa kwekutanga kwe SARS-CoV-2 virus test.

Kune varwere vari panjodzi huru yekuenderera mberi kwechirwere, kuendeswa kuchipatara uye kushanya mumakamuri ekukurumidzira (ER) kwakaitika mu3 muzana yevarwere vakarapwa nebamlanivimab paavhareji zvichienzaniswa ne10 muzana muvarwere vakarapwa neplacebo.

Migumisiro pahuwandu hwehutachiona uye pakudzikira kwekuiswa muchipatara uye kushanya kweER, uye pakuchengetedzwa, zvaive zvakafanana kune varwere vaigamuchira chero ipi zvayo yemishonga mitatu yebamlanivimab, sekureva kweFDA.

EUA inobvumira kuti bamlanivimab igoverwe uye ipihwe mushonga mumwe chete nevanopa hutano.

"Mvumo yeFDA yekubata bamlanivimab inopa vashandi vehutano vari pamberi pedenda iri chimwe chishandiso chinogona kushandiswa mukurapa varwere veCOVID-19," akadaro Patrizia Cavazzoni, mukuru weFDA's Center for Drug Evaluation and Research. "Ticharamba tichiongorora data idzva pamusoro pekuchengetedzeka uye kushanda kwebamlanivimab sezvavanowanikwa."

Zvichibva pakuongorora humbowo hwesainzi huripo, FDA yakaona kuti zvine musoro kutenda kuti bamlanivimab inogona kushanda pakurapa varwere vasiri muchipatara vane COVID-19 iri pakati nepakati kana kuti isina kunyanya kuipa. Uye, kana ikashandiswa kurapa COVID-19 kuvanhu vane mvumo, mabhenefiti anozivikanwa uye anogona kuitika anopfuura njodzi dzinozivikanwa uye dzinogona kuitika dzemushonga uyu, sekureva kweFDA.

Migumisiro inogona kuitika yebamlanivimab inosanganisira anaphylaxis uye kupindirana neinfusion, kuda kurutsa, manyoka, dzungu, musoro, kuvaviwa uye kurutsa, sekureva kwesangano iri.

EUA yauya apo United States yadarika mamiriyoni gumi evanhu vane COVID-19 neMuvhuro, mazuva gumi chete mushure mekunge yasvika mamiriyoni mapfumbamwe. Avhareji yehuwandu hwehutachiona hutsva hwezuva nezuva hwapfuura zviuru zana, uye nyanzvi dzehutano dzeveruzhinji dzakayambira kuti nyika iri kupinda muchikamu chakaipisisa chedenda iri.