Kubva muna 2021-08-24, Cara Therapeutics nemumwe wayo webhizinesi Vifor Pharma yakazivisa kuti yayo yekutanga-mu-kirasi kappa opioid receptor agonist difelikefalin (KORSUVA™) yakabvumidzwa neFDA kurapwa kwechirwere cheitsvo chisingaperi (CKD) varwere. (yakanaka Pakati/yakaoma pruritus ine hemodialysis kurapwa), inotarisirwa kutangwa muna 2022Q1.Cara naVifor vakasaina chibvumirano cherezinesi chega chekutengesa KORSUVA™ muUnited States uye vakabvuma kutengesa KORSUVA™ kuFresenius Medical.Pakati pavo, Cara uye Vifor mumwe nomumwe ane 60% uye 40% purofiti chikamu mukutengesa mari kunze Fresenius Medical;imwe neimwe ine 50% purofiti chikamu mumari yekutengesa kubva kuFresenius Medical.
CKD-yakabatana pruritus (CKD-aP) inguva yakajairwa pruritus inoitika nepamusoro frequency uye kusimba muvarwere veCKD vari kuita dialysis.Pruritus inoitika munenge 60% -70% yevarwere vanowana dialysis, iyo 30% -40% vane pruritus iri pakati nepakati / yakaoma, iyo inokanganisa zvakanyanya hupenyu hwehupenyu (semuenzaniso, kusarara zvakanaka) uye inobatanidza nekuora mwoyo.Iko hakuna kurapwa kunoshanda kweCKD-kwakabatana pruritus kare, uye kubvumidzwa kweDifelikefalin kunobatsira kugadzirisa gaka rakakura rekuda kwekurapa.Mvumo iyi yakavakirwa pamakiriniki maviri akakosha eChikamu chechitatu mukunyora kweNDA: data rakanaka kubva kuKALM-1 uye KALM-2 miedzo muUS uye pasi rose, uye tsigiro kubva kune makumi matatu nemaviri ekuwedzera zvidzidzo zvekiriniki, izvo zvinoratidza kuti KORSUVA ™ inoshivirirwa zvakanaka. .
Munguva pfupi yapfuura, nhau dzakanaka dzakabva kukiriniki yekudzidza yefelikefalin muJapan: 2022-1-10, Cara yakazivisa kuti vadyidzani vayo Maruishi Pharma naKissey Pharma vakasimbisa kuti jekiseni rekufalikefalin rinoshandiswa muJapan kurapa pruritus muvarwere vehemodialysis.Phase III miedzo yemakiriniki Mhedzisiro yekutanga yakasangana.Varwere 178 vakagamuchira mavhiki matanhatu edifelikefalin kana placebo uye vakapinda muchidzidzo chekuwedzera-masvondo makumi mashanu nemaviri.Mhedziso yekutanga (shanduko yepruritus nhamba yenhamba chiyero chechiyero) uye chechipiri chekupedzisira (kuchinja mune itch mamakisi paShiratori Severity Scale) yakagadziridzwa zvakanyanya kubva kune yekutanga muboka difelikefalin kana ichienzaniswa neboka re placebo uye yakatenderwa zvakanaka.
Difelikefalin ikirasi yeopioid peptides.Kubva pane izvi, Peptide Research Institute yakadzidza zvinyorwa zveopioid peptides, uye yakapfupisa kuoma uye mazano eopioid peptides mukugadzirwa kwezvinodhaka, pamwe chete nemamiriro ezvinhu ekugadzirisa zvinodhaka.
Nguva yekutumira: Feb-17-2022