FDA ta Amince da Farko COVID-19 Jiyya ga Kananan Yara

A yau, Hukumar Kula da Abinci da Magunguna ta Amurka ta faɗaɗa amincewar maganin COVID-19 na Veklury (remdesivir) don haɗawa da marasa lafiya na yara masu shekaru 28 da haihuwa masu nauyin aƙalla kilo 3 (kimanin fam 7) tare da kyakkyawan sakamako na kai tsaye SARS-CoV- 2 gwaje-gwaje na viral, wadanda sune:    

•            Ana asibiti, ko

•          Ba a kwance a asibiti kuma suna da COVID-19 mai sauƙi zuwa matsakaici kuma suna cikin haɗarin ci gaba zuwa mummunan COVID-19, gami da asibiti ko mutuwa.

Wannan aikin ya sa Veklury ya zama farkon yarda da maganin COVID-19 ga yara waɗanda ba su wuce shekaru 12 ba. Sakamakon amincewa da matakin na yau, hukumar ta kuma soke izinin yin amfani da gaggawa ga Veklury wanda a baya ya rufe wannan adadin na yara.

Kafin yanzu, an amince da Veklury kawai don kula da wasu manya da marasa lafiya na yara (shekaru 12 da haihuwa waɗanda suke aƙalla kilo 40, wanda kusan fam 88) tare da COVID-19.

Patrizia Cavazzoni, MD, darektan ya ce "Kamar yadda COVID-19 na iya haifar da rashin lafiya mai tsanani a cikin yara, waɗanda a halin yanzu ba su da zaɓin rigakafin, ana ci gaba da buƙatar amintattun zaɓuɓɓukan magani na COVID-19 ga wannan yawan." na Cibiyar Nazarin Magunguna da Magunguna ta FDA. "Yin amincewa da yau na farkon maganin COVID-19 ga wannan jama'a yana nuna himmar hukumar ga wannan buƙata."

Veklury ba madadin alluran rigakafi ba ne a cikin mutane waɗanda aka ba da shawarar rigakafin COVID-19 da ƙarin allurai. FDA ta amince da alluran rigakafi guda biyu, kuma akwai alluran rigakafi guda uku don amfani da gaggawa, don hana COVID-19 da mummunan sakamakon asibiti da ke da alaƙa da COVID-19, gami da asibiti da mutuwa. FDA ta bukaci jama'a da su yi allurar rigakafi kuma su sami abin ƙarfafawa lokacin da suka cancanta. Ƙara koyo game da yarda da FDA-da kuma izini na rigakafin COVID-19.

Idan aka ba da irin wannan yanayin cutar COVID-19 a cikin manya da marasa lafiya na yara, amincewar yau na Veklury a cikin wasu marasa lafiyar yara yana samun goyan bayan sakamako mai inganci daga gwaji na asibiti na kashi 3 a cikin manya. Ana iya samun bayanai game da gwaji a cikin manya a cikin lakabin magani da FDA ta amince da shi don Veklury. Hakanan ana samun goyan bayan wannan amincewa ta wani lokaci na 2/3, hannu-da-hannu, bincike-bincike na asibiti na marasa lafiya na yara 53 aƙalla kwanaki 28 kuma suna yin nauyi aƙalla kilo 3 (kimanin fam 7) tare da tabbatar da kamuwa da cuta ta SARS-CoV-2. kuma mai laushi, matsakaici ko mai tsanani COVID-19. Marasa lafiya a cikin wannan gwajin na yara 2/3 sun karɓi Veklury har zuwa kwanaki 10. Sakamakon aminci da pharmacokinetic daga nazarin lokaci na 2/3 a cikin batutuwan yara sun kasance kama da na manya.

Fom ɗin da aka yarda kawai shine Veklury don allura. 

Abubuwan da za a iya haifar da amfani da Veklury sun haɗa da matakan haɓakar hanta enzymes, wanda zai iya zama alamar raunin hanta; da rashin lafiyan halayen, wanda zai iya haɗawa da canje-canje a cikin hawan jini da bugun zuciya, ƙarancin iskar oxygen, zazzabi, rashin ƙarfi na numfashi, numfashi, kumburi (misali, lebe, a kusa da idanu, a ƙarƙashin fata), rash, tashin zuciya, gumi ko rawar jiki.

FDA ta ba da izini ga Gilead Sciences Inc.