Ho tloha ka 2021-08-2024, Cara Therapeutics le molekane oa eona oa khoebo Vifor Pharma ba phatlalalitse hore sehlopha sa eona sa pele sa kappa opioid receptor agonist difelikefalin (KORSUVA™) se amohetsoe ke FDA bakeng sa kalafo ea bakuli ba lefu la liphio le sa foleng (CKD). (positive pruritus e itekanetseng / e matla ka kalafo ea hemodialysis), e lebelletsoe ho qala ka 2022Q1.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 cheleteng ea thekiso e tsoang ho Fresenius Medical.
CKD-associated pruritus (CKD-aP) ke pruritus e akaretsang e hlahang khafetsa le ho 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 ipapisitse le liteko tse peli tsa bohlokoa tsa Phase III tlalehong ea NDA: lintlha tse nepahetseng tse tsoang litekong tsa KALM-1 le KALM-2 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 Qetellong ea mantlha e ile ea fihleloa.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 pruritus rating rating scale score) le ntlha ea bobeli ea ho qetela (ho fetoha ha palo ea ho hlohlona ho Shiratori Severity Scale) e ile ea ntlafatsoa haholo ho tloha qalong ea sehlopha sa difelikefalin ha se bapisoa le sehlopha sa placebo 'me se mamelloa hantle.
Difelikefalin ke sehlopha sa li-peptide tsa opioid.E 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