Kwangoko ngo-2021-08-24, i-Cara Therapeutics kunye neqabane layo loshishino uVifor Pharma ubhengeze ukuba i-kappa opioid receptor agonist yeklasi yokuqala difelikefalin (KORSUVA™) yamkelwe yi-FDA yonyango lwezifo ezingapheliyo zezintso (CKD) izigulane (i-potive Moderate / i-pruritus enzima kunye ne-hemodialysis2 elindelekileyo kukuqaliswa kwe-hemodia22). UCara kunye noVifor batyikitye isivumelwano selayisensi esikhethekileyo sokuthengisa i-KORSUVA™ e-United States kwaye bavuma ukuthengisa i-KORSUVA™ kwiFresenius Medical. Phakathi kwabo, iCara kunye neVifor nganye inesabelo se-60% kunye ne-40% yenzuzo kwingeniso yokuthengisa ngaphandle kweFresenius Medical; nganye ine-50% yesabelo senzuzo kwingeniso yokuthengisa evela kwiFresenius Medical.
I-pruritus ehambelana ne-CKD (CKD-aP) yi-pruritus eqhelekileyo eyenzeka ngokuphindaphindiweyo kunye nokuqina kwizigulane ze-CKD eziphantsi kwe-dialysis. I-Pruritus yenzeke malunga ne-60% -70% yezigulane ezifumana i-dialysis, apho i-30% -40% ine-pruritus ephakathi / enzima, echaphazela kakhulu umgangatho wobomi (umz., ukungalali kakuhle) kwaye ihambelana nokudakumba. Alukho unyango olusebenzayo lwe-CKD-enxulumene ne-pruritus ngaphambili, kwaye imvume ye-Difelikefalin inceda ukujongana nomsantsa omkhulu wemfuno yonyango. Olu gunyaziso lusekwe kulingo lwezonyango olungundoqo lweSigaba sesi-III ekufakweni kwe-NDA: idatha elungileyo evela kulingo lwe-KALM-1 kunye ne-KALM-2 e-US nakwihlabathi jikelele, kunye nedatha exhasayo evela kwizifundo zeklinikhi ezongezelelweyo ezingama-32, ezibonisa ukuba i-KORSUVA ™ inyamezeleke kakuhle.
Kungekudala, iindaba ezimnandi zavela kuphononongo lwezonyango lwe-difelikefalin eJapan: 2022-1-10, iCara yabhengeza ukuba amaqabane ayo uMaruishi Pharma kunye noKissey Pharma baqinisekise ukuba inaliti ye-difelikefalin isetyenziswa eJapan kunyango lwe-pruritus kwizigulana ze-hemodialysis. ISigaba sesi-III solingo lwezonyango Isiphelo sokuqala sahlangatyezwana. Izigulane ezingama-178 zifumene iiveki ezi-6 ze-difelikefalin okanye i-placebo kwaye zathatha inxaxheba kuphononongo oluvulekileyo lweeveki ezingama-52. Isiphelo sokuqala (utshintsho kwi-pruritus yamanqaku okulinganisa ukulinganisa kwamanani) kunye nesiphelo sesibini (utshintsho kwinqaku lokurhawuzelelwa kwi-Shiratori Severity Scale) ziphuculwe kakhulu ukusuka kwisiseko kwiqela le-difelikefalin xa kuthelekiswa neqela le-placebo kwaye zinyanyezelwe kakuhle.
I-Difelikefalin luhlobo lwe-opioid peptides. Ngokusekelwe koku, i-Peptide Research Institute ifunde uncwadi kwiipeptides ze-opioid, kwaye yashwankathela ubunzima kunye nezicwangciso ze-opioid peptides ekuphuhliseni amachiza, kunye nemeko yangoku yophuhliso lwamachiza.
Ixesha lokuposa: Feb-17-2022