Chithandizo Chatsopano cha deensitization kwa odwala omwe ali ndi vuto lopatsira impso

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Written by Linda Hohnholz

Hansa Biopharma AB, "Hansa" lero alengeza kuti chithandizo chake choyambirira cha Idefirix® (imlifidase) chapatsidwa chilolezo chotsatsa malonda (Autorisation d'accès précoce) ku France ndi French HAS (Haute Autorité de Santé) kuti agwiritsidwe ntchito. m'maganizo a odwala akuluakulu okhudzidwa kwambiri asanawaike impso, malinga ndi chiwerengero cha odwala chomwe chatchulidwa mu Marketing Authorization yolandiridwa kuchokera ku European Medicines Agency (EMA).1,2

Cholinga cha mapulogalamu ofikira msanga ku France ndikufulumizitsa mwayi wopeza mankhwala anzeru asanavomerezedwe kutsatsa (AP1) kapena pambuyo (AP2) (komanso musanamalize ndondomeko yonse ya P&R), monga momwe zinalili ndi Idefirix® pomwe zonse zotsatirazi zidanenedwa. munkhani L.5121-12 ya French Public Health Code (CSP) zakwaniritsidwa:

• Palibe chithandizo choyenera chomwe chilipo pamsika;

• Kuyambika kwa chithandizo sikungachedwe;

• Kuchita bwino ndi chitetezo cha mankhwala akuganiziridwa mwamphamvu kutengera zotsatira za mayesero a zachipatala; ndi

• Mankhwalawa amaganiziridwa kuti ndi otsogola, makamaka powayerekeza ndi ofananitsa okhudzana ndi zachipatala.

Kuvomerezedwa kwa pulogalamu yofikira msanga ya Idefirix® ndizovomerezeka kwa chaka chimodzi kuyambira tsiku lachigamulo, zoperekedwa ndi National Security System, ndipo zimagwira ntchito m'malo onse opangira impso ku France. Chilolezochi chaperekedwa kutengera zomwe a Hansa adalemba mu Disembala 2021, zomwe zidapereka malingaliro abwino a Transparency Commission. Zambiri za pulogalamu yofikira koyambirira zitha kupezeka patsamba la HAS.

Pafupifupi 3,600 kuyika impso kumachitika chaka chilichonse ku France, ndipo oposa 80% amawaika kuchokera kwa omwe adamwalira. mndandanda wodikirira womuika aimpso anali 3%. 

Søren Tulstrup, Purezidenti ndi CEO, anati: , Hansa Biopharma. "Kupereka Idefirix® ngati njira yatsopano yothandizira odwala a impso okhudzidwa kwambiri ku France kukuwonetsa kudzipereka kwathu pakupititsa patsogolo miyoyo ya odwala omwe ali ndi matenda osowa chitetezo chamthupi."

Dialysis yanthawi yayitali imatha kubweretsa zovuta zambiri kwa odwala komanso machitidwe azachipatala ndipo imalumikizidwa ndi kuchepa kwa moyo wokhudzana ndi thanzi komanso chiopsezo cha kufa komanso kugonekedwa kuchipatala.4-6

Kuyambitsa malonda ndi ntchito zopezera msika kwa Idefirix® ku Ulaya zikupitirizabe kupita patsogolo. Mitengo ndi kubweza ndalama zamalizidwa ku Sweden ndi Netherlands, komanso pachipatala cha munthu aliyense ku Finland ndi Greece. Njira zopezera msika zikupitilira m'maiko 14 kuphatikiza Germany, France, Italy ndi United Kingdom (UK). Dongosolo la Health Technology Assessment (HTA) la Spain lidatumizidwa mu Januware 2022, lomwe linamaliza zolemba za HTA m'misika yonse yayikulu isanu ku Europe.

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Linda Hohnholz

Mkonzi wamkulu kwa eTurboNews zochokera ku eTN HQ.

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