Tsis ntev los no, Tuam Tshoj Lub Chaw Tswj Xyuas Khoom Noj thiab Tshuaj (SFDA) tau lees paub daim ntawv thov kev lag luam ntawm tafolecimab (PCSK-9 Monoclonal antibody uas yog tsim los ntawm INNOVENT BIOLOGICS, INC), INC rau kev kho mob ntawm thawj hypercholesterolemia (xws li heterozygous familial hypercholesterolemia thiab tsis yog tsev neeg. hypercholesterolemia) thiab sib xyaw dyslipidemia.Qhov no yog thawj tus kheej tsim PCSK-9 inhibitor los thov kev lag luam hauv Suav teb.
Tafolecimab yog ib qho tshuaj lom neeg tshiab tsim los ntawm INNOVENT BIOLOGICS, INC. IgG2 tib neeg monoclonal antibody tshwj xeeb khi PCSK-9 kom nce qib LDLR los ntawm kev txo PCSK-9-mediated endocytosis, yog li nce LDL-C tshem tawm thiab txo qis LDL-C qib.
Nyob rau hauv xyoo tas los no, kev nthuav dav ntawm dyslipidemia tau nce ntau hauv Suav teb.Feem ntau ntawm dyslipidemia thiab hypercholesterolemia hauv cov neeg laus yog siab li 40.4% thiab 26.3% feem.Raws li tsab ntawv tshaj tawm xyoo 2020 ntawm Kev Noj Qab Haus Huv thiab Kab Mob hauv Suav teb, kev kho thiab tswj tus nqi ntawm dyslipidemia hauv cov neeg laus tseem nyob rau theem qis, thiab LDL-C ua raws li cov neeg mob dyslipidemia tseem tsis txaus siab.
Yav dhau los, statins yog cov kev kho mob tseem ceeb rau hypercholesterolemia hauv Suav teb, tab sis ntau tus neeg mob tseem ua tsis tiav cov hom phiaj kho mob ntawm LDL-C txo qis tom qab kho.Kev lag luam ntawm PCSK-9 tau coj cov txiaj ntsig zoo rau cov neeg mob.
Kev xa tawm ntawm tafolecimab los ntawm INNOVENT BIOLOGICS, INC yog ua raws li cov txiaj ntsig ntawm peb qhov kev sim tshuaj uas tau sau npe hauv theem kev ywj pheej, Nws muaj qhov zoo tag nrho kev nyab xeeb profile, zoo ib yam li cov yam ntxwv kev nyab xeeb ntawm cov khoom lag luam, thiab tau ua tiav ntev (txhua 6 lub lis piam) ntawm kev tswj hwm.Cov txiaj ntsig ntawm CREDIT-2 txoj kev tshawb fawb tau txais los ntawm 2022 Lub Rooj Sib Tham Txhua Xyoo ntawm American College of Cardiology (ACC) raws li kev paub daws teeb meem thiab luam tawm hauv online.
Yog tias daim ntawv thov raug pom zoo, nws yuav rhuav tshem qhov kev tsis sib haum xeeb ntawm impoeted PCSK-9, Tuam Tshoj yuav dhau los ua lub tebchaws thib plaub uas muaj PCSK-9 tom qab Tebchaws Meskas (Amgen), Fabkis (Sanofi) thiab Switzerland (Novartis).
Lub sij hawm xa tuaj: Plaub Hlis-04-2022