Hukumar Abinci da Magunguna ta Amurka, FDA ta amince da wani sabon magani da ake jira sosai wanda aka ƙera don rage radadin ciwon marasa lafiya a cikin ƙananan matakai na farkon cutar Alzheimer.
Kimanin Amurkawa miliyan 6.5 suna fama da cutar Alzheimer, wanda ke da alaƙa da asarar ƙwaƙwalwa da karancin hankali.
Amincewar FDA na maganin, Leqembi, wanda kuma aka sani da lecanemab, ya zo ne kwanaki bayan da aka soki hukumar gudanarwa a cikin rahoton majalisar saboda hasken kirkiro wani maganin Alzheimer, Aduhelm.
Dukansu magungunan an yarda dasu ta hanyar hanzarin tsari wanda ke ba FDA damar saurin amincewa da magunguna don yanayi mai tsanani inda akwai buƙatar likita da ba ta cika ba.
FDA ta ce a cikin wata sanarwa cewa “Leqembi da Aduhelm, wadanda Eisai na Japan da Biogen na Amurka suka haɓaka, suna wakiltar wani muhimmin ci gaba a cikin yaƙin da ake yi na magance cutar Alzheimer yadda ya kamata.”
Sanarwar ta nakalto Billy Dunn na Cibiyar Nazarin Magunguna da Bincike na Hukumar yana cewa, “Cutar Alzheimer ba ta da iyaka ga rayuwar wadanda ke fama da ita kuma tana da illa ga ‘yan uwansu.”
Ya ce “Leqembi, sabon maganin da za a yi niyya da kuma shafar tsarin cutar Alzheimer, maimakon kawai magance alamun cutar.”
An fitar da bayanan farko na gwaji na Leqembi a watan Satumba kuma an gano cewa yana rage raguwar fahimi a cikin masu cutar Alzheimer da kashi 27 cikin ɗari.
Gwajin kashi na uku ya shafi mutane kusan 1,800, wanda aka raba tsakanin wadanda aka bai wa maganin kuma aka ba su wuribo, kuma ya shafe sama da watanni 18.
Cikakken bayanan gwaji, wanda aka buga a cikin New England Journal of Medicine, ya tayar da damuwa game da abin da ya faru na “sakamako marasa kyau” ciki har da zubar da jini da kumburi.
Sakamakon ya nuna cewa kashi 17.3 cikin 100 na marasa lafiya da ke gudanar da maganin sun sami zubar jini na kwakwalwa, idan aka kwatanta da kashi tara na wadanda ke karbar placebo. Kuma kashi 12.6 cikin 100 na masu shan miyagun ƙwayoyi sun sami kumburin kwakwalwa, idan aka kwatanta da kashi 1.7 kawai na waɗanda ke cikin rukunin placebo.
An bayar da rahoton mace-mace a kusan daidai gwargwado a duka makamai biyu na gwajin maganin.
A cikin cutar Alzheimer, sunadaran sunadarai guda biyu, tau da amyloid beta, suna ginawa zuwa tangles da plaques, waɗanda aka sani tare da haɗuwa, wanda ke sa ƙwayoyin kwakwalwa su mutu kuma suna haifar da raguwar kwakwalwa.
Leqembi, wanda ake gudanarwa ta cikin jijiya sau ɗaya a kowane mako biyu, yana aiki ta hanyar kai hari amyloid.
A cikin gwaji, marasa lafiya da ke karɓar Leqembi sun sami raguwar ƙididdiga a cikin plaque amyloid na kwakwalwa idan aka kwatanta da hannun placebo, wanda ba shi da raguwar amyloid beta plaque.
A baya dai Biogen da Eisai sun kawo Aduhelm kasuwa, amma an yi ta cece-kuce kan ko yana aiki, kuma amincewarsa a shekarar 2021 ya haifar da murabus din manyan matakai uku a cikin FDA.
Wani bincike na Majalisar Dokokin Amurka ya ce tsarin amincewa da hanzari ga Aduhelm, magani na farko da aka amince da shi a cikin shekaru da yawa don magance cutar Alzheimer, “ya cika da rashin bin ka’ida” kuma ya soki hukumar da Biogen.
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