Ho tloha ka 2021-08-24, Cara Therapeutics le molekane oa eona oa khoebo Vifor Pharma ba phatlalalitse hore mofuta oa eona oa pele oa "kappa opioid receptor agonist" difelikefalin (KORSUVA™) o amohetsoe ke FDA bakeng sa kalafo ea lefu le sa foleng la liphio (CKD) Cara le Vifor ba saenetse tumellano e khethehileng ea laesense bakeng sa thekiso ea KORSUVA™ United States 'me ba lumellana ho rekisa KORSUVA™ ho Fresenius Medical. Har'a bona, Cara le Vifor e mong le e mong o na le karolo ea 60% le 40% ea phaello ea chelete ea thekiso ntle le Fresenius Medical; e 'ngoe le e 'ngoe e na le karolo ea 50% ea phaello ea chelete ea thekiso e tsoang ho Fresenius Medical.
CKD-associated pruritus (CKD-aP) ke pruritus e akaretsang e hlahang khafetsa le ka matla ho bakuli ba CKD ba ntseng ba etsoa dialysis. Pruritus e hlaha hoo e ka bang 60% -70% ea bakuli ba fumanang dialysis, eo 30% -40% ea bona ba nang le pruritus e itekanetseng / e matla, e amang haholo boleng ba bophelo (mohlala, boleng bo bobe ba ho robala) 'me e amahanngoa le ho tepella maikutlong. Ha ho na kalafo e sebetsang bakeng sa pruritus e amanang le CKD pele, mme tumello ea Difelikefalin e thusa ho rarolla lekhalo le leholo la tlhoko ea bongaka. Tumello ena e theiloe holim'a liteko tse peli tsa bohlokoa tsa Mokhahlelo oa III ho file NDA: lintlha tse nepahetseng tse tsoang litekong tsa KALM-1 le KALM-2 tsa US le lefats'e ka bophara, le lintlha tse tšehetsang tse tsoang lithutong tse ling tse 32 tsa bongaka, tse bonts'ang hore KORSUVA ™ e mamellehile hantle.
Hase khale haholo, litaba tse monate li tsoa thutong ea bongaka ea difelikefalin Japane: 2022-1-10, Cara e phatlalalitse hore balekane ba eona Maruishi Pharma le Kissey Pharma ba tiisitse hore ente ea difelikefalin e sebelisoa Japane bakeng sa phekolo ea pruritus ho bakuli ba hemodialysis. Liteko tsa kliniki tsa Phase III Qetello ea mantlha e ile ea finyelloa. Bakuli ba 178 ba amohetse libeke tse 6 tsa difelikefalin kapa placebo mme ba kentse letsoho thutong ea katoloso ea li-label ea libeke tse 52. Qetello e ka sehloohong (ho fetoha ha palo ea litekanyetso tsa palo ea pruritus) le ntlha ea bobeli ea ho qetela (ho fetoha ha lintlha tsa ho hlohlona ho Shiratori Severity Scale) li ile tsa ntlafatsoa haholo ho tloha qalong ea sehlopha sa difelikefalin ha se bapisoa le sehlopha sa placebo 'me se ile sa mamelloa hantle.
Difelikefalin ke sehlopha sa li-peptide tsa opioid. Ho itšetlehile ka sena, Peptide Research Institute e ithutile lingoliloeng ka li-peptide tsa opioid, 'me e akaretsa mathata le maqheka a li-peptide tsa opioid ntlafatsong ea lithethefatsi, hammoho le boemo ba hona joale ba nts'etsopele ea lithethefatsi.
Nako ea poso: Feb-17-2022