Ọgwụgwọ Mbugharị Akụrụ Ọhụrụ

A Jide Free Ntọhapụ 6 | eTurboNews | eTN

Hansa Biopharma AB taa kwuputara na onye ọrịa mbụ na akara ngosi US mepere emepe, enweghị usoro, nke a na-achịkwa nke ukwuu (“ConfIdeS”) edebanyela aha na Columbia University Medical Center, New York. Nnwale ConfIdeS na-enyocha imlifidase dị ka ọgwụgwọ nwere ike ime ka ọ ghara ime ka ọ nwee ike ịmịnye akụrụ n'ime ndị ọrịa nwere oke uche na-echere akụrụ inye onyinye nwụrụ anwụ site na sistemụ oke akụrụ US.

A na-atụ anya na nnwale a ga-eme ka ndị ọrịa na-atụgharị akụrụ 64 nwere uche nke ukwuu nwere cPRA nke ≥99.9%, na-anọchite anya akụkụ nke ndị ọrịa nwere oke mmetụta nke na-aga n'ihu na-enwe nkụda mmụọ n'agbanyeghị ebute ụzọ n'okpuru usoro oke akụrụ US. Mgbe akụkụ ahụ na-enye onyinye dị, ma nkwekọrịta dị mma na onye e bu n'obi na-egosi na akụkụ ahụ adabaghị, a ga-ekewa onye ọrịa ahụ ka ọ bụrụ ọgwụgwọ enweghị mmasị ma ọ bụ na ogwe aka nchịkwa nke ga-enweta ọkọlọtọ nlekọta (ya bụ ichere maka ihe ga-adaba adaba karịa). akụrụ na-enye ma ọ bụ na-anata ọgwụgwọ adịghị ike nnwale). Isi njedebe ọmụmụ ihe maka imlifidase iji nyochaa uru dị n'ịkwanye ndị ọrịa nwere uche nke ukwuu bụ ọrụ aka akụrụ na ọnwa 12, nke eGFR tụrụ (atụmatụ Glomerular Filtration Rate).

Ebumnobi nke ikpe ConfIdeS dabara na “Akwalite Ahụike Kidney America” (“AAKH”) US Executive Order (https://kidney360.asnjournals.org/content/1/6/557), nke gbadoro ụkwụ na gburugburu atọ sara mbara. ihe mgbaru ọsọ: (1) ibelata ihe ize ndụ nke ọdịda akụrụ; (2) imeziwanye ohere ịnweta na ogo nhọrọ ọgwụgwọ dabere na mmadụ; na (3) na-abawanye ohere maka ntụgharị akụrụ, ebe abụọ nke ikpeazụ jikọtara ya na ịgbasa transplant.

Robert A. Montgomery, MD, Prọfesọ nke ịwa ahụ na onye isi, NYU Langone Transplant Institute na New York City, ka a họpụtala onye nyocha nhazi nke mba maka nnwale ConfIdeS. Ọnwụnwa ahụ ga-edebanye aha ndị ọrịa na ụlọ ọrụ ntụgharị 12 ruo 15 na US

A na-atụ anya imecha ndebanye aha na ule ahụ na ọkara nke abụọ nke 2022, na-atụ anya na a ga-emecha usoro ọmụmụ ihe ọnwa 12 na ọkara nke abụọ nke 2023. A na-atụ anya na nsonaazụ sitere na nnwale a dị mkpa ga-akwado nkwado BLA nwere ike ime. FDA n'okpuru ụzọ nkwado ngwa ngwa na ọkara mbụ nke 2024.

Imlifidase enwetala nkwado ahịa ahịa ọnọdụ na Europe maka ọgwụgwọ enweghị uche nke ndị ọrịa na-atụgharị akụrụ okenye nwere uche nke ukwuu nwere njikọ dị mma megide onye nyere onyinye nwụrụ anwụ dị.

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Linda Hohnholz

Onye nchịkọta akụkọ maka eTurboNews dabere na eTN HQ.

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