I-Rezdiffra (resmetirom): I-FDA ivuma unyango lokuQala lweSibindi ngenxa yeSifo sesibindi esinamafutha. 

I-Rezdiffra (resmetirom) ivunyiwe yi-FDA yase-USA kunyango lwabantu abadala abane-noncirrhotic non-alcoholic steatohepatitis (NASH) ene-moderate to advanced yesibindi scarring (fibrosis), ukuba isetyenziswe kunye nokutya kunye nokuzilolonga.  

Ukuza kuthi ga ngoku, izigulane ezine-steatohepatitis engeyiyo i-cirrhotic non-alcoholic (NASH) ezinazo nezibazi zesibindi eziphawulekayo azizange zibe namayeza anokulungisa umonakalo wesibindi sazo . Ukuvunywa yi-FDA yiRezdiffra, okokuqala, kuza kubonelela ngonyango kwezi zigulane, ukongeza ekutyeni nasekuzilolongeni.

I-NASH yimbangela yokuqhubela phambili kwesifo sesibindi esinamafutha esinganxilisiyo apho ukudumba kwesibindi , ngokuhamba kwexesha, kunokukhokelela ekuqhekekeni kwesibindi kunye nokungasebenzi kakuhle kwesibindi. I-NASH idla ngokunxulunyaniswa nezinye iingxaki zempilo ezifana noxinzelelo lwegazi oluphezulu kunye nesifo seswekile sohlobo lwesibini. Ubuncinane uqikelelo olunye, malunga nezigidi ezi-6-8 zabantu e-US bane-NASH enezibazi zesibindi eziphakathi ukuya kweziphambili, kwaye elo nani kulindeleke ukuba linyuke.

I-Rezdiffra yi-activator inxalenye ye-receptor yehomoni ye-thyroid; ukusebenza kwale receptor nguRezdiffra kwisibindi kunciphisa ukuqokelela kwamafutha esibindi.  

Ukhuseleko kunye nokusebenza kakuhle kweRezdiffra  

Ukhuseleko kunye nokusebenza kakuhle kweRezdiffra kuhlolwe ngokusekelwe kuhlalutyo lwe-surrogate endpoint kwinyanga ye-12 kuvavanyo lwe-placebo olulawulwa yi-placebo lweenyanga ezingama-54, olucwangcisiweyo, olungaboni kabini. I-surrogate endpoint ilinganise ubungakanani bokudumba kwesibindi kunye nokuqhekeka. Umxhasi kufuneka enze uphando emva kokuvunywa ukuqinisekisa nokuchaza inzuzo yeklinikhi yeRezdiffra, oluya kwenziwa ngokugqiba uphando olufanayo lweenyanga ezingama-54, olusaqhubeka. Ukuze babhalise kuvavanyo, izigulane kwakufuneka zenze i- biopsy yesibindi ebonisa ukudumba ngenxa ye-NASH enezibazi zesibindi eziphakathi okanye eziphambili . Kuvavanyo, abantu abangama-888 babelwa ngokungacwangciswanga ukuba bafumane enye yezi zilandelayo: i-placebo (abantu abangama-294); ii-80 milligrams zeRezdiffra (abantu abangama-298); okanye ii-100 milligrams zeRezdiffra (abantu abangama-296); kanye ngemini, ukongeza kunyango oluqhelekileyo lwe-NASH, oluquka iingcebiso zokutya okunempilo kunye nokuzilolonga.

Kwiinyanga ezili-12, ii-biopsy zesibindi zibonise ukuba inani elikhulu labantu abafumene unyango ngeRezdiffra lifikelele kwisisombululo se-NASH okanye ukuphucuka kwamanxeba esibindi xa kuthelekiswa nabo bafumana i-placebo. Inani elipheleleyo lama-26% ukuya kuma-27% abantu abafumene ii-80 milligrams zeRezdiffra kunye nama-24% ukuya kuma-36% abantu abafumene ii-100 milligrams zeRezdiffra baye bafumana isisombululo se-NASH kwaye akukho manxeba esibindi aqhubekayo, xa kuthelekiswa ne-9% ukuya kwi-13% yabo bafumana i-placebo kunye nengcebiso malunga nokutya kunye nokuzilolonga. Uluhlu lweempendulo lubonisa ukufundwa okwahlukeneyo kweengcali zezifo. Ukongeza, inani elipheleleyo lama-23% abantu abafumene ii-80 milligrams zeRezdiffra kunye nama-24% ukuya kuma-28% abantu abafumene ii-100 milligrams zeRezdiffra baye bafumana ukuphucuka kwamanxeba esibindi kwaye akukho manxeba esibindi aqhubekayo, xa kuthelekiswa ne-13% ukuya kwi-15% yabo bafumana i-placebo, kuxhomekeke kukufundwa kwengcali nganye yezifo. Ukubonakaliswa kwezi nguqu kwinani lezigulana emva konyaka omnye nje zonyango kuyaphawuleka, njengoko esi sifo sidla ngokuqhubeka kancinci uninzi lwezigulana luthatha iminyaka okanye amashumi eminyaka ukubonisa ukuqhubela phambili.

Iziphumo ebezingalindelekanga zeRezdiffra  

Ezona ziphumo zixhaphakileyo zeRezdiffra ziquka urhudo kunye nesicaphucaphu. I-Rezdiffra iza nezilumkiso ezithile kunye nezilumkiso, ezinje ngetyhefu yesibindi esenziwe ngamachiza kunye neziphumo ebezingalindelekanga ezinxulumene ne-gallbladder.  

Ukusetyenziswa kweRezdiffra kufuneka kuthintelwe kwizigulana ezine-decompensated cirrhosis. Izigulana maziyeke ukusebenzisa iRezdiffra ukuba zifumanisa iimpawu okanye iimpawu zokusebenza kwesibindi okuya kusiba mandundu ngelixa zisekunyangweni lweRezdiffra.

Ukusebenzisana kweziyobisi kweRezdiffra  

Ukusebenzisa i-Rezdiffra ngaxeshanye njengamanye amachiza athile, ngakumbi amayeza okunciphisa i-cholesterol, kunokubangela intsebenziswano ebalulekileyo yamachiza. Ababoneleli bezempilo kufuneka babhekiselele kwingcaciso epheleleyo yokumisela ulwazi olongezelelweyo malunga nolu nxibelelwano lwamachiza olunokuba lubalulekileyo kunye ne-Rezdiffra, idosi ecetyiswayo kunye nokuguqulwa kolawulo.  

I -FDA ivumile iRezdiffra phantsi kwendlela yokwamkelwa ngokukhawuleza, evumela ukuvunywa kwangaphambili kwamayeza anyanga iimeko ezinzulu kwaye ajongane nesidingo sezonyango esingafezekiswanga, ngokusekelwe kwisiphelo seklinikhi esingaphezulu kwesinye okanye esiphakathi esinokuqikelela inzuzo yeklinikhi. Uphononongo olufunekayo lweenyanga ezingama-54 olukhankanyiweyo ngaphambili, oluqhubekayo, luza kuvavanya inzuzo yeklinikhi emva kweenyanga ezingama-54 zonyango lweRezdiffra.

I-Rezdiffra ifumene i-Breakthrough Therapy, i-Fast Track kunye ne-Priority Review ukutyunjwa kolu phawu.  

I -FDA ivumile iRezdiffra kwiMadrigal Pharmaceuticals.

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umthombo: 

I-FDA 2024. Iindaba ezikhutshwe yi-FDA – I-FDA Ivuma Unyango Lokuqala Lwezigulane Ezinezibazi Zesibindi Ngenxa Yesifo Sesibindi Esinamafutha. Iposiwe nge-14 kaMatshi 2024. Ifumaneka apha https://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-patients-liver-scarring-due-fatty-liver-disease

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