FDA nqaim qhia rau Biogen's Alzheimer's Disease Tshuaj Tshiab

Thaum Lub Rau Hli 7, FDA, txawm hais tias muaj kev tawm tsam ntawm Pawg Kws Tshaj Lij Muab Tswv Yim, ua kom pom zoo tshiab ntawm Biogen/Eisai Alzheimer's disease (AD) tshuaj Aduhelm (aducanumab-avwa) raws li biomarker lwm qhov kawg, uas ua rau 3 pawg neeg tawm mus. cov tswv cuab, ua rau muaj kev lag luam Muaj teeb meem loj.

Thaum Lub Xya Hli 8, Biogen tshaj tawm tias FDA tau hloov kho Aduhelm cov lus qhia. Qhov hloov tshiab suav nrog ua kom nqaim ntawm cov pejxeem uas siv tau thiab cov txheej txheem ntawm kev siv los ua kom nws zoo ib yam nrog theem kab mob thiab cov pejxeem tau kawm hauv kev sim tshuaj. Qhov no kuj yog FDA' cov lus teb rau ib qho ntawm kev lag luam' qhov teeb meem muaj teeb meem.

Cov hauv qab no yog kev sib piv ntawm ua ntej thiab tom qab hloov tshiab. Nws tau pom zoo yav dhau los rau cov neeg mob AD, thiab hloov tshiab nag hmo tsuas yog rau cov neeg mob uas muaj kev paub tsis meej me me lossis nyob rau theem ntawm kev nco qab me me.

Aducanumab' kev pom zoo tau ua rau muaj kev nce hauv Biogen' cov khoom lag luam, thiab cov tuam txhab lag luam tshuaj loj tau hla thaj chaw kab mob hauv nruab nrab xws li AD. Eli Lilly cov tshuaj AD tshiab donanemab lub hom phiaj N3pG-hloov kho Aβ protein yeej tau txais kev kho mob los ntawm FDA thiab npaj yuav xa daim ntawv thov kev lag luam hauv lub xyoo no. Bristol-Myers Squibb tau txais $ 2.2 nphom los ntawm AD cov tshuaj tshiab los tiv thaiv tau tshuaj tiv thaiv kab mob. Simcere qhia ob hom tshuaj AD tshiab, Roche Nrhiav xa daim ntawv thov kev lag luam rau Aβ antibody gantenerumab rau FDA thiab lwm yam.