Namuhla, i-US Food and Drug Administration inwebise ukugunyazwa kokwelashwa kwe-COVID-19 i-Veklury (remdesivir) ukuthi ifake iziguli zezingane ezinezinsuku ezingama-28 ubudala nangaphezulu ezinesisindo esingamakhilogremu ama-3 (cishe amakhilogremu ayi-7) ngemiphumela emihle ye-SARS-CoV- eqondile. 2 ukuhlolwa kwegciwane, okuyizi:

• Ukulaliswa esibhedlela, noma

• Abalalisiwe esibhedlela futhi bane-COVID-19 emaphakathi kuya kokumaphakathi futhi basengozini enkulu yokudlulela ku-COVID-19 enzima, okuhlanganisa ukulaliswa esibhedlela noma ukufa.

Lesi senzo senza i-Veklury ibe eyokuqala egunyazwe ukwelashwa kwe-COVID-19 ezinganeni ezingaphansi kweminyaka engu-12 ubudala. Njengomphumela wesenzo sanamuhla sokugunyaza, i-ejensi iphinde yahoxisa ukugunyazwa kokusetshenziswa kwezimo eziphuthumayo kwe-Veklury ebikade ihlanganisa lesi sibalo sezingane.

Ngaphambi kwamanje, iVeklury yayigunyazwe kuphela ukwelapha abantu abadala abathile kanye neziguli zezingane (ezineminyaka eyi-12 nangaphezulu ezinesisindo esingamakhilogremu angama-40, okungamakhilogremu angama-88) nge-COVID-19.

"Njengoba i-COVID-19 ingadala ukugula kakhulu ezinganeni, ezinye zazo ezingenayo indlela yokugoma njengamanje, kusaqhubeka kunesidingo sezindlela zokwelapha eziphephile nezisebenzayo ze-COVID-19 zalesi sibalo," kusho uPatrizia Cavazzoni, MD, umqondisi. Yesikhungo Se-FDA Sokuhlola Nokucwaninga Kwezidakamizwa. "Ukuvunywa kwanamuhla kwendlela yokuqala yokwelapha i-COVID-19 kulaba bantu kukhombisa ukuzibophezela kwale nhlangano kuleso sidingo."

I-Veklury ayithathi indawo yokugoma kubantu okunconyelwe ukugonyelwa i-COVID-19 kanye nemithamo ye-booster. I-FDA igunyaze imigomo emibili, kanti imigomo emithathu iyatholakala ukuze isetshenziswe ezimweni eziphuthumayo, ukuvimbela i-COVID-19 kanye nemiphumela yomtholampilo ebucayi ehlobene ne-COVID-19, okuhlanganisa ukulaliswa esibhedlela nokufa. I-FDA inxusa umphakathi ukuthi ugonywe futhi uthole i-booster uma kufanele. Funda kabanzi mayelana nemithi yokugomela i-COVID-19 egunyazwe futhi egunyaziwe yi-FDA.

Njengoba kunikezwe inkambo efanayo yesifo se-COVID-19 kubantu abadala nasezigulini zezingane, ukugunyazwa kwanamuhla kwe-Veklury ezigulini ezithile zezingane kusekelwa imiphumela yokuphumelela evela ezivivinyweni zomtholampilo zesigaba sesi-3 kubantu abadala. Ulwazi ngovivinyo kubantu abadala lungatholakala ekulebeni kwezidakamizwa ezigunyazwe yi-FDA ze-Veklury. Lokhu kugunyazwa futhi kusekelwa isigaba 2/3, ingalo eyodwa, ucwaningo lomtholampilo olunelebula evulekile lweziguli zezingane ezingama-53 okungenani izinsuku ezingama-28 ubudala futhi ezinesisindo esingamakhilogremu ama-3 (cishe amakhilogremu ayi-7) ezinokutheleleka okuqinisekisiwe kwe-SARS-CoV-2. kanye ne-COVID-19 ethambile, emaphakathi noma eqinile. Iziguli ezikulesi sivivinyo sesigaba 2/3 sezingane zithole i-Veklury izinsuku ezingafika kweziyi-10. Imiphumela yokuphepha kanye ne-pharmacokinetic yocwaningo lwesigaba 2/3 ezifundweni zezingane yayifana neyabantu abadala.

Ifomu lemithamo eligunyaziwe kuphela i-Veklury yomjovo.

Imiphumela emibi engase ibe khona yokusebenzisa i-Veklury ihlanganisa amazinga anda ama-enzyme esibindi, okungase kube uphawu lokulimala kwesibindi; kanye nokungezwani komzimba, okungase kuhlanganise izinguquko kumfutho wegazi nokushaya kwenhliziyo, izinga eliphansi le-oksijini egazini, imfiva, ukuphelelwa umoya, ukushaywa umoya, ukuvuvukala (isb., izindebe, eduze kwamehlo, ngaphansi kwesikhumba), ukuqubuka, isicanucanu, ukujuluka noma ukuqhaqhazela.

I-FDA inikeze imvume kwaGileyadi Sciences Inc.

LOKHO ONGAKUTHATHE KULESI SIHLOKO:

This approval is also supported by a phase 2/3, single-arm, open-label clinical study of 53 pediatric patients at least 28 days of age and weighing at least 3 kilograms (about 7 pounds) with confirmed SARS-CoV-2 infection and mild, moderate or severe COVID-19.
Food and Drug Administration expanded the approval of the COVID-19 treatment Veklury (remdesivir) to include pediatric patients 28 days of age and older weighing at least 3 kilograms (about 7 pounds) with positive results of direct SARS-CoV-2 viral testing, who are.
Given the similar course of COVID-19 disease in adults and pediatric patients, today’s approval of Veklury in certain pediatric patients is supported by efficacy results from phase 3 clinical trials in adults.