Rezdiffra (resmetirom): FDA ta Amince da Magani na Farko don Taɓan Hanta Saboda Cutar Hanta mai Fatty 

Rezdiffra (resmetirom) FDA ta Amurka ta amince da ita don kula da manya masu fama da ciwon steatohepatitis maras-giya (NASH) tare da matsakaici zuwa ci-gaba na hanta (fibrosis), don amfani da abinci tare da motsa jiki.  

Har zuwa yanzu, marasa lafiya da ke fama da cutar steatohepatitis (NASH) waɗanda kuma ke da tabon hanta mai tsanani ba su da maganin da zai iya magance lalacewar hantarsu kai tsaye . Amincewar FDA ta Rezdiffra, a karon farko, za ta samar da zaɓin magani ga waɗannan marasa lafiya, ban da abinci da motsa jiki.

NASH sakamakon ci gaban cututtukan hanta masu kitse marasa giya ne inda kumburin hanta , akan lokaci, zai iya haifar da tabon hanta da rashin aikin hanta. Ana danganta NASH da wasu matsalolin lafiya kamar hawan jini da ciwon suga na nau'in 2. Aƙalla kiyasi ɗaya, kimanin mutane miliyan 6-8 a Amurka suna da NASH tare da tabon hanta mai matsakaici zuwa mai tsanani, kuma ana sa ran wannan adadin zai ƙaru.

Rezdiffra wani sashi ne mai kunnawa na mai karɓar hormone thyroid; kunna wannan mai karɓa ta hanyar Rezdiffra a cikin hanta yana rage yawan kitsen hanta.  

Aminci da ingancin Rezdiffra  

An kimanta aminci da ingancin Rezdiffra bisa ga nazarin ƙarshen maganin maye a watan 12 a cikin gwajin da aka yi na watanni 54, wanda aka sarrafa ta hanyar placebo, wanda aka yi ta hanyar bazuwar, wanda aka yi ta hanyar makanta biyu. Matsakaicin maganin ya auna girman kumburi da tabo na hanta . Ana buƙatar mai tallafawa ya gudanar da bincike bayan amincewa don tabbatarwa da bayyana fa'idar asibiti ta Rezdiffra, wanda za a yi ta hanyar kammala wannan binciken na watanni 54, wanda har yanzu yana ci gaba. Don yin rajista a cikin gwajin, marasa lafiya suna buƙatar yin gwajin hanta wanda ke nuna kumburi saboda NASH tare da tabo na hanta mai matsakaici ko ci gaba . A cikin gwajin, an ba wa mutane 888 bazuwar don karɓar ɗaya daga cikin waɗannan: placebo (mutane 294); milligram 80 na Rezdiffra (mutane 298); ko milligram 100 na Rezdiffra (mutane 296); sau ɗaya a rana, ban da kulawa ta yau da kullun ga NASH, wanda ya haɗa da ba da shawara don abinci mai kyau da motsa jiki.

Bayan watanni 12, binciken ƙwayoyin cuta na hanta ya nuna cewa mafi yawan waɗanda aka yi wa magani da Rezdiffra sun sami nasarar rage tabon hanta ko kuma inganta tabon hanta idan aka kwatanta da waɗanda aka yi wa magani da placebo. Jimillar kashi 26 zuwa 27% na waɗanda aka yi wa magani da Rezdiffra milligrams 80 da kuma kashi 24 zuwa 36% na waɗanda aka yi wa magani da Rezdiffra milligrams 100 sun sami nasarar rage tabon hanta kuma babu wani mummunan tabon hanta da ya taɓo, idan aka kwatanta da kashi 9 zuwa 13% na waɗanda aka yi wa magani da kuma ba da shawara kan abinci da motsa jiki. Yawan amsoshin da aka bayar ya nuna karatun masana cututtuka daban-daban. Bugu da ƙari, jimillar kashi 23% na waɗanda aka yi wa magani da Rezdiffra milligrams 80 da kuma kashi 24 zuwa 28% na waɗanda aka yi wa magani da Rezdiffra milligrams 100 sun sami ci gaba a tabon hanta kuma babu taɓowar NASH, idan aka kwatanta da kashi 13 zuwa 15% na waɗanda aka yi wa magani da placebo, ya danganta da karatun kowane likitan cututtuka. Nuna waɗannan canje-canje a cikin adadin marasa lafiya bayan shekara ɗaya kawai na magani abin lura ne, domin cutar yawanci tana ci gaba a hankali inda yawancin marasa lafiya ke ɗaukar shekaru ko ma shekaru da dama don nuna ci gaba.

Tasirin Rezdiffra  

Mafi yawan illolin Rezdiffra sun haɗa da gudawa da tashin zuciya. Rezdiffra ya zo tare da wasu gargaɗi da taka tsantsan, kamar gubar hanta da ke haifar da ƙwayoyi da illa masu alaƙa da gallbladder.  

Ya kamata a guji amfani da Rezdiffra ga marasa lafiya da ke fama da cutar cirrhosis mai ƙarancin albashi. Ya kamata marasa lafiya su daina amfani da Rezdiffra idan suka ga alamun rashin aikin hanta yayin da suke shan maganin Rezdiffra.

Hanyoyin hulɗar miyagun ƙwayoyi na Rezdiffra  

Yin amfani da Rezdiffra a lokaci guda da wasu magunguna, musamman statins don rage cholesterol, na iya haifar da yuwuwar mu'amalar magunguna. Ma'aikatan kiwon lafiya yakamata su koma ga cikakken bayanin bayanin don ƙarin bayani akan waɗannan yuwuwar hulɗar magunguna tare da Rezdiffra, shawarar sashi da gyare-gyaren gudanarwa.  

Hukumar FDA ta amince da Rezdiffra a ƙarƙashin hanyar amincewa da sauri, wadda ke ba da damar amincewa da magunguna da wuri waɗanda ke magance cututtuka masu tsanani da kuma magance buƙatar likita da ba a cika ba, bisa ga wani magani na maye gurbin ko matsakaicin matakin asibiti wanda zai iya hasashen fa'idar asibiti. Binciken da aka ambata a sama na watanni 54, wanda ke ci gaba da gudana, zai tantance fa'idar asibiti bayan watanni 54 na maganin Rezdiffra.

Rezdiffra ya karɓi Ƙwararrun Farfadowa, Saurin Hanya da Nasihun Bita na Farko don wannan alamar.  

Hukumar FDA ta amince da Rezdiffra ga Madrigal Pharmaceuticals.

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Source: 

FDA 2024. Sanarwar Labarai – FDA Ta Amince Da Maganin Farko Ga Marasa Lafiya Da Ke Da Tabon Hanta Saboda Ciwon Hanta Mai Kitse. An Buga a ranar 14 ga Maris, 2024. Akwai a https://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-patients-liver-scarring-due-fatty-liver-disease

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