I-Hansa Biopharma AB, “Hansa” namuhla imemezele ukuthi ukwelashwa kwayo kwesigaba sokuqala i-Idefirix® (imlifidase) inikezwe imvume yokufinyelela ngaphambi kwesikhathi yokuthengisa (Autorisation d'accès précoce) e-France yi-French HAS (Haute Autorité de Santé) ukuze isetshenziswe. ekuqedeni ukuzwela kweziguli ezikhulile ezizwela kakhulu ngaphambi kokufakelwa izinso, ngokuvumelana nenani leziguli elishiwo Kugunyazo Lokumaketha elitholwe ku-European Medicines Agency (EMA).1,2
Inhloso yezinhlelo zokufinyelela kusenesikhathi e-France ukusheshisa ukufinyelela emithini emisha ngaphambi kokugunyazwa kokumaketha kwe-(AP1) noma (AP2) (nangaphambi kokuphothulwa kwenqubo egcwele ye-P&R), njengasendabeni ye-Idefirix® lapho yonke imibandela elandelayo ibalulwe. esihlokweni esithi L.5121-12 seKhodi Yezempilo Yomphakathi YaseFrance (CSP) kuyahlangatshezwana nayo:
• Akukho ukwelashwa okufanele okutholakalayo emakethe;
• Ukuqaliswa kokwelashwa ngeke kuhlehliswe;
• Ukusebenza nokuphepha komkhiqizo womuthi kucatshangelwa ngokuqinile ngokusekelwe emiphumeleni yokuhlolwa komtholampilo; futhi
• Umuthi womuthi uthathwa njengomusha, ikakhulukazi uma uqhathaniswa nesiqhathanisi esihlobene nomtholampilo.
Ukugunyazwa kwalolu hlelo lokufinyelela kusenesikhathi lwe-Idefirix® kusebenza unyaka kusukela ngosuku lwesinqumo, oluxhaswe nge-National Security System, futhi lusebenza kuzo zonke izikhungo zokufakelwa izinso eFrance. Ukugunyazwa kunikezwe ngokusekelwe kudosi le-Hansa elithunyelwe ngoDisemba 2021, elinikeze umbono omuhle weKhomishini Yokungafihli. Imininingwane egcwele yohlelo lokufinyelela kusenesikhathi ingatholakala kusizindalwazi se-HAS.
Cishe ukufakelwa kwezinso ezingu-3,600 kwenziwa minyaka yonke eFrance, okungaphezu kuka-80% kutshalwa kabusha kubanikeli abashonile. uhlu lokulinda ukufakelwa izinso lube ngama-3%.
"Iziguli zezinso ezinamazinga aphezulu amasosha omzimba e-HLA phambilini zibe nokufinyelela okulinganiselwe ekufakweni kwezinso ngenxa yokuntuleka kokwelashwa okuphumelelayo kokuqeda ukuzwela, futhi ngokuvamile azinayo enye indlela ngaphandle kokuhlala ku-dialysis yesikhathi eside," kusho uSøren Tulstrup, uMongameli kanye ne-CEO. , uHansa Biopharma. "Ukuletha i-Idefirix® njengendlela yokwelapha entsha yeziguli zezinso ezizwela kakhulu eFrance kubonisa ukuzibophezela kwethu ekwenzeni ngcono izimpilo zeziguli ezinezimo ezingavamile zokugonywa."
I-dialysis yesikhathi eside ingabeka umthwalo omkhulu ezigulini nasezinhlelweni zokunakekelwa kwempilo futhi ihlotshaniswa nokunciphisa izinga lempilo elihlobene nempilo kanye nengozi eyengeziwe yokufa nokulaliswa esibhedlela.4-6
Ukwethulwa kwezohwebo kanye nemizamo yokufinyelela emakethe ye-Idefirix® eYurophu iyaqhubeka nokuthuthuka. Izinqubo zamanani nembuyiselo seziqediwe eSweden naseNetherlands, kanye nasesibhedlela ngasinye eFinland naseGreece. Izinqubo zokufinyelela emakethe ziyaqhubeka emazweni ayi-14 ahlanganisa iJalimane, iFrance, i-Italy kanye ne-United Kingdom (UK). Idosi ye-Health Technology Assessment (HTA) yaseSpain yathunyelwa ngoJanuwari 2022, eyaphothula ukufakwa kwe-HTA kuzo zonke izimakethe ezinhlanu ezinkulu eYurophu.
LOKHO ONGAKUTHATHE KULESI SIHLOKO:
- The aim of early access programs in France is to accelerate access to innovative medicines before (AP1) or after (AP2) marketing authorization (and before completion of the full P&R process), as in the case of Idefirix® when all the following conditions stipulated in article L.
- Today announced that its first-in-class treatment Idefirix® (imlifidase) has been granted early access post marketing authorization (Autorisation d’accès précoce) in France by French HAS (Haute Autorité de Santé) for use in the desensitization of highly sensitized adult patients prior to kidney transplant, in accordance with the patient population specified in the Marketing Authorization received from the European Medicines Agency (EMA).
- The approval of this early access program for Idefirix® is valid for a year from the date of decision, funded through the National Security System, and is effective across kidney transplant centers in France.
