Ua hoʻolaha ʻo Hansa Biopharma AB, "Hansa" i kēia lā ua hāʻawi ʻia kāna lāʻau lapaʻau mua ʻo Idefirix® (imlifidase) i ka ʻae ʻana ma hope o ke kūʻai aku ʻana (Autorization d'accès précoce) ma Farani e ka French HAS (Haute Autorité de Santé) no ka hoʻohana. i ka desensitization o ka nui sensitized makua maʻi ma mua o ka kidney transplant, e like me ka heluna kanaka maʻi i hoakaka ia ma ka Marketing Authorization loaa mai ka European Medicines Agency (EMA).1,2

ʻO ka pahuhopu o nā polokalamu komo mua ma Farani, ʻo ia ka wikiwiki o ka loaʻa ʻana o nā lāʻau lapaʻau hou ma mua o (AP1) a ma hope paha (AP2) ka mana kūʻai aku (a ma mua o ka pau ʻana o ke kaʻina hana P&R piha), e like me ka hihia o Idefirix® i ka wā i ʻōlelo ʻia ai nā kūlana āpau. ma ka ʻatikala L.5121-12 o ka French Public Health Code (CSP) i hui ʻia:

• ʻAʻohe lāʻau lapaʻau kūpono i loaʻa ma ka mākeke;

• ʻAʻole hiki ke hoʻopaneʻe ʻia ka hoʻomaka ʻana o ka lāʻau;

• Ua manaʻo nui ʻia ka maikaʻi a me ka palekana o ka lāʻau lapaʻau ma muli o nā hopena o nā hoʻokolohua lapaʻau; a

• Manaʻo ʻia he mea hou ka lāʻau lapaʻau, ʻoi aku ka maikaʻi o ka hoʻohālikelike ʻia me ka mea hoʻohālikelike pili pili kino.

ʻO ka ʻae ʻia ʻana o kēia polokalamu komo mua no Idefirix® he mea kūpono ia no hoʻokahi makahiki mai ka lā i hoʻoholo ai, i hoʻopaʻa kālā ʻia ma o ka National Security System, a he kūpono ia ma nā kikowaena transplant kidney ma Farani. Ua hāʻawi ʻia ka ʻae e pili ana i ka dossier a Hansa i waiho ʻia ma Dekemaba 2021, i hāʻawi ʻia i kahi manaʻo maikaʻi o ke Komisina Transparency. Hiki ke loaʻa nā kikoʻī piha o ka papahana komo mua ma ka pūnaewele HAS.

Ma kahi o 3,600 mau transplantations kidney e hana ʻia i kēlā me kēia makahiki ma Farani, me ka ʻoi aku o ka 80% i hoʻololi ʻia mai nā mea hāʻawi i make.3 Wahi a ka Agence de Biomédecine, i ka makahiki 2020 hyperimmune nā mea maʻi i hōʻike ʻia he 11.1% o ka poʻe i loaʻa i nā mea maʻi maʻi, ʻoiai ka hapa o nā mea maʻi hyperimmune ma ka ikaika. ʻO 23.7% ka papa inoa kali e hoʻololi i ka renal.

"ʻO nā poʻe maʻi me nā kiʻekiʻe o ka HLA antibodies ua loaʻa i ka liʻiliʻi loa ke komo ʻana i nā transplants kidney ma muli o ka nele o nā lāʻau desensitization maikaʻi, a ʻaʻohe mea ʻē aʻe a lākou e noho ai ma ka dialysis lōʻihi," wahi a Søren Tulstrup, Pelekikena a Luna Nui. , Hansa Biopharma. "ʻO ka hāʻawi ʻana iā Idefirix® ma ke ʻano he koho lapaʻau hou no nā poʻe maʻi maʻi maʻi koʻikoʻi ma Farani e hōʻike ana i kā mākou kūpaʻa i ka hoʻomaikaʻi ʻana i ke ola o nā maʻi me nā maʻi immunological lohi."

Hiki i ka dialysis lōʻihi ke kau i kahi kaumaha nui ma luna o nā maʻi a me nā ʻōnaehana mālama olakino a pili pū me ka hoʻemi ʻana i ka maikaʻi o ke ola e pili ana i ke olakino a me ka piʻi nui ʻana o ka make a me ka hoʻokipa.4-6

Ke hoʻomau nei ka holomua ʻana o ka hoʻolaha ʻana a me ka mākeke no Idefirix® ma ʻEulopa. Ua hoʻopau ʻia nā kaʻina hana kumu kūʻai a me ka hoʻihoʻi hou ʻana ma Sweden a me Netherlands, a ma kahi hale hoʻomaha hoʻokahi ma Finland a me Helene. Ke hoʻomau nei nā kaʻina hana ma ka mākeke ma 14 mau ʻāina me Kelemania, Farani, Italia a me United Kingdom (UK). Ua hoʻouna ʻia kahi palapala Health Technology Assessment (HTA) no Sepania ma Ianuali 2022, nāna i hoʻopau i nā faila HTA ma nā mākeke ʻelima nui loa ma ʻEulopa.

He aha e lawe ʻia mai kēia ʻatikala:

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.