Biogen xa daim ntawv thov rau cov npe ntawm Alcanheimer kab mob tshuaj aducanumab

Biogen thiab Eisai koom ua ke tshaj tawm tias Biogen tau ua tiav Kev xa Daim Ntawv Tso Cai Bioproduct Daim Ntawv Thov (BLA) rau Asmeskas Chaw Tswj Xyuas Khoom Noj thiab Tshuaj (FDA), nrhiav kev pom zoo rau kev kho kab mob Alzheimer (AD). Tshawb nrhiav tshuaj aducanumab. Daim ntawv thov no suav nrog cov ntaub ntawv kuaj mob los ntawm Theem 3 kev soj ntsuam kev sim EMERGE thiab ENGAGE thiab Theem 1b chaw kuaj mob sim ua ntej. Bojian kuj tseem nrhiav kom tau txais kev tshuaj xyuas kev ua ntej ua ntej. Yog tias tau txais kev pom zoo, aducanumab yuav yog thawj zaug kev pom zoo los ntawm FDA los txhawm rau ncua kev poob ntawm cov tsos mob hauv Alzheimer' s tus kab mob, thiab nws tseem yuav yog thawj qhov ua pov thawj tias tshem tawm beta-amyloid protein tuaj yeem ua tiav zoo dua cov chaw kuaj mob. Cov.

Alzheimer' s tus kab mob yog ib qho kev mob tshwm sim hauv lub cev ua kom txoj kev xav tsis zoo, nco thiab kev ywj pheej, uas ua rau muaj kev tuag ntxov. Tus kab mob no yog tus muaj kev noj qab haus huv thoob ntiaj teb uas cuam tshuam rau cov neeg mob thiab lawv tsev neeg. Raws li cov ntaub ntawv los ntawm World Health Organization (WHO), kaum tawm lab tus tib neeg thoob ntiaj teb muaj Alzheimer' s tus kab mob, thiab tus lej no yuav txuas ntxiv nyob rau xyoo tom ntej.

Aducanumab (BIIB037) yog cov tshuaj monoclonal antibody nyob hauv kev tshawb nrhiav hom phiaj amyloid beta. Bojian tau txais cov ntaub ntawv tshawb fawb thiab kev loj hlob ntawm aducanumab los ntawm Neuroimmune. Txij li thaum Lub Kaum Hlis 2017, Bojian thiab Eisai tau tsim thiab ua lag luam aducanumab thoob plaws ntiaj teb.

Aducanumab qhov kev tsim kho mob muaj xws li ob ntu 3 kev soj ntsuam kuaj mob EMERGE thiab ENGAGE, nqa tawm hauv cov neeg mob Alzheimer' s thaum ntxov. Qhov chaw kuaj mob sim sai mus txog nws thawj qhov chaw kuaj mob. Nyob rau ntawm 78 lub limtiam ntawm cov tshuaj tiv thaiv aducanumab, nws ua rau qeeb tus nqi ntawm qhov poob ntawm qhov peev xwm kev txawj ntse (CDR-SB) piv rau cov placebo (22%, p=0.01). Aducanumab kuj tau mus txog ntau qhov kawg ua haujlwm kawg rau hauv kev sim EMERGE.

Kev ntsuas cov ntaub ntawv ntawm amyloid tso rau hauv kev sim sim EMERGE tau qhia tias ntawm 26 thiab 78 lub lis piam, amyloid plaque load tau txo qis hauv pawg qis-thiab siab aducanumab pawg piv rau cov placebo (P< 0.001).="" txawm="" hais="" tias="" qhov="" kev="" sim="" engage="" tsis="" ncav="" cuag="" nws="" qhov="" kawg,="" bo="" jian="" ntseeg="" tias="" ib="" feem="" ntawm="" nws="" cov="" ntaub="" ntawv="" txhawb="" nqa="" cov="" kev="" tshawb="" fawb="" soj="" ntsuam="" hauv="" emerge="" kev="">

GG quot; Alzheimer' s tus kab mob tseem yog ib qhov kev sib tw noj qab haus huv loj tshaj plaws ntawm peb lub sijhawm," hais tias Biogen CEO Mr. Michel Vounatsos:" Nws ua rau cov neeg mob nco qab, muaj kev ywj pheej, thiab thaum kawg ua rau cov neeg peb hlub ua tsis tau Muaj peev xwm ua tiav cov haujlwm yooj yim. Peb tos ntsoov rau FDA tshuaj xyuas peb daim ntawv thov."