ʻO Concizumab (Alhemo) no ka Hemophilia A a i ʻole B me nā mea pale

Concizumab (inoa kalepa, Alhemo), ua ʻae ʻia kahi antibody monoclonal e ka FDA ma ka lā 20 Dekemaba 2024 no ka pale ʻana i nā ʻāpana koko i nā mea maʻi me ka hemophilia A me nā mea hoʻopaneʻe kumu VIII a i ʻole hemophilia B me nā mea hoʻopale IX. Ua loaʻa iā ia ka ʻae ʻia e ka European Medicines Agency (EMA) i kekahi mau lā i hala ma 16 Dekemaba 2024 no nā hōʻailona like.

ʻO kekahi poʻe maʻi hemophilia ma "nā lāʻau clotting factor" no ka mālama ʻana i ko lākou maʻi maʻi koko e hoʻomohala i nā antibodies (kūʻē i nā lāʻau clotting factor). ʻO nā antibodies i hoʻokumu ʻia ke kāohi i ka hana o nā "lāʻau clotting factor" i emi iho ka hopena. Hoʻomaʻamaʻa ʻia kēia maʻi i kēia manawa e ka hoʻoulu ʻana i ka hoʻomanawanui ʻole ma o nā injections i kēlā me kēia lā o nā kumu clotting. Hāʻawi ka ʻae ʻana iā Concizumab (Alhemo) i kēlā mau maʻi i kahi lapaʻau ʻē aʻe.

Hoʻohana ʻia ʻo Concizumab i kēlā me kēia lā ma ke ʻano he subcutaneous injection.

Hoʻokumu ʻia ka ʻae ʻana o Alhemo ma luna o ka loiloi o kona palekana a me ka pono i loko o kahi hoʻokolohua lapaʻau multi-national, multi-centre, open-label, phase 3. I ka ho'āʻo, ua ho'ēmiʻia ka makahiki makahiki (ABR) e 86% no ka hui lapaʻau Alhemo i hoʻohālikelikeʻia me ka huiʻole prophylaxis.

Hoʻokumu ʻia nā maʻi koko i ka hemophilia ma muli o ka lawa ʻole o nā kumu clotting. Hoʻokumu ʻia ka maʻi hemophilia A ma muli o ka hemahema o ke kumu clotting VIII, aʻo ka hemophilia B ma muli o nā haʻahaʻa haʻahaʻa o ka helu IX. ʻO ka nele o ka mea hana XI ke kuleana no ka hemophilia C. Hoʻomaʻamaʻa ʻia kēia mau maʻi ma o ka hoʻokomo ʻana i ka mea hoʻohui i hoʻomākaukau ʻia ma ke kālepa a i ʻole kahi huahana kumu ʻole ma ke ʻano he hana pani o ka mea i nalowale.

ʻO Octocog alfa (Advate), ʻo ia ka 'genetically engineered me ka hoʻohana ʻana i ka ʻenehana DNA' version of clotting factor VIII, i hoʻohana mau ʻia no ka pale a me ka mālama ʻana i ka hemophilia A. No ka hemophilia B, nonacog alfa (BeneFix), ka mea. he mana hoʻohana ʻia o ka clotting factor IX i hoʻohana mau ʻia.

Hympavzi (marstacimab-hncq), he kanaka monoclonal antibody e huli ana i ka "tissue factor pathway inhibitor" ua apono hou ia ma ke ano he laau lapaau hou no ka pale ana i ke koko o na kanaka me ka hemophilia A a me ka hemophilia B.

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E hoʻomaopopo ':

Ua ʻae ʻo FDA i ka lāʻau lapaʻau e pale a hōʻemi paha i ke alapine o ka hoʻokahe koko no nā poʻe maʻi me ka hemophilia A me nā mea paʻa a i ʻole hemophilia B me nā mea paʻa. Hoʻopuka ʻia 20 Dekemaba 2024. Loaʻa ma https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-drug-prevent-or-reduce-frequency-bleeding-episodes-patients-hemophilia-inhibitors-or