Hansa Biopharma AB, "Hansa" nhasi yazivisa kuti kurapa kwayo kwekutanga-mu-kirasi Idefirix® (imlifidase) yakapihwa mvumo yekukurumidza kuwana post yekushambadzira (Autorisation d'accès précoce) muFrance neFrench HAS (Haute Autorité de Santé) kuti ishandiswe. mukudzvinyirirwa kwevarwere vakura vane ruzivo rwakanyanya vasati vaiswa itsvo, maererano nehuwandu hwevarwere hwakatsanangurwa muKushambadzira Authorization yakagamuchirwa kubva kuEuropean Medicines Agency (EMA).1,2
Chinangwa chezvirongwa zvekusvika kwekutanga muFrance kukurumidza kukurumidza kuwana mishonga yekuvandudza pamberi (AP1) kana mushure (AP2) mvumo yekushambadzira (uye isati yapedzwa yeP&R yakazara maitiro), sezvakaita Idefirix® apo zvese zvinotevera zvinongedzo zvakatemwa. muchinyorwa L.5121-12 cheFrench Public Health Code (CSP) zvakasangana:
• Hapana kurapwa kwakakodzera kunowanikwa pamusika;
• Kutanga kurapwa hakugone kuverengerwa;
• Kubudirira uye kuchengeteka kwechigadzirwa chemishonga inofungidzirwa zvakasimba zvichienderana nemigumisiro yemakiriniki ekuedzwa; uye
• Mushonga wemushonga unofungidzirwa kuva mutsva, kunyanya kana uchienzaniswa nemuenzanisi unoenderana nekiriniki.
Mvumo yeiyi purogiramu yekukurumidza yekuwana yeIdefirix® inoshanda kwegore kubva pazuva resarudzo, inotsigirwa nemari kuburikidza neNational Security System, uye inoshanda munzvimbo dzese dzeitsvo muFrance. Mvumo yakapihwa zvichibva pagwaro raHansa rakaunzwa muna Zvita 2021, iro rakapa maonero akanaka eTransparency Commission. Ruzivo rwakazara rwechirongwa chekutanga chekuwana chinogona kuwanikwa pawebhusaiti yeHAS.
Inenge 3,600 yeitsvo transplantation inoitwa gore negore muFrance, uye inopfuura 80% yakasimwa kubva kune vakafa vakafa. renal transplant yekumirira list yaive 3%.
"Varwere veitsvo vane huwandu hwakawanda hweHLA masoja ekudzivirira chirwere vakambove vasina mukana wekutapurirana itsvo nekuda kwekushaikwa kwekurapa kunoshanda kwedesensitization, uye kazhinji havana imwe nzira kunze kwekuramba vari padialysis kwenguva refu," anodaro Søren Tulstrup, Mutungamiriri uye CEO. , Hansa Biopharma. "Kuendesa Idefirix® senzira nyowani yekurapa kune varwere veitsvo vanonyanya kunzwisiswa muFrance kunoratidza kuzvipira kwedu kuvandudza hupenyu hwevarwere vane zvisingawanzo kudzivirirwa zvirwere."
Dialysis yenguva refu inogona kuisa mutoro mukuru kune varwere uye pazvirongwa zvehutano hwehutano uye inosanganiswa nekuderera kwehutano hwehutano hwehupenyu uye kuwedzera kwengozi yekufa uye kuchipatara.4-6
Kutanga kwekutengeserana uye kuedza kuwana misika yeIdefirix® muEurope inoramba ichifambira mberi. Mitengo uye nzira dzekudzorera dzakapedzwa muSweden neNetherlands, pamwe chete nechipatara chega muFinland neGreece. Matanho ekuwana musika arikuenderera mberi munyika gumi neina dzinosanganisira Germany, France, Italy neUnited Kingdom (UK). A Health Technology Assessment (HTA) dossier yeSpain yakaunzwa muna Ndira 14, iyo yakapedzisa kunyorwa kweHTA mumisika mishanu mikuru muEurope.
ZVOKUBVA MUNYAYA INO:
- 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.
