Novartis / Amgen Aimovig: Lub taub hau-rau-lub taub hau Theem 4 kev kho mob, kev zam tau zoo dua thiab ua tau zoo hauv kev tiv thaiv mob taub hau dua li topiramate!

Novartis thiab Amgen tsis ntev los no tshaj tawm tias thawj theem IV, randomized, ob-dig muag, ob-dummy, taub hau-rau-lub taub hau kawm HER-MES (NCT03828539) los ntsuas cov tshuaj migraine Aimovig (erenumab) tau luam tawm hauv Phau ntawv kho mob [ GG] quot; Cephalalgia".

Txoj kev tshawb fawb HER-MES tau ua nyob rau hauv 777 cov neeg laus cov neeg mob uas muaj mob migraine (EM) lossis mob migraine (CM) uas tsis tau txais yav tas los, lossis tsis tsim nyog, lossis tau txais txog 3 qhov kev tiv thaiv kab mob migraine uas ua tsis tiav. Tus naj npawb ntawm migraine hnub (MMD) ≥4 hnub hauv cov neeg mob no ib hlis. Txoj kev tshawb no tau muab piv rau Aimovig (70mg thiab 140mg) nrog rau cov koob tshuaj siab tshaj plaws (50-100mg / hnub) ntawm topiramate (topiramate). Topiramate yog ib qho tshuaj tiv thaiv kab mob thiab feem ntau siv los ua tus qauv kev kho mob rau kev tiv thaiv migraine. Tus naj npawb ntawm cov neeg mob tshuaj tshiab hauv Tebchaws Meskas yog siab txog 600,000 txhua xyoo.

Cov txiaj ntsig tau pom tias piv nrog topiramate, Aimovig muaj kev ua siab ntev thiab ua tau zoo hauv kev tiv thaiv migraine. Tshwj xeeb: (1) Aimovig tau txais txiaj ntsig zoo dua li topiramate, thiab tus nqi rho tawm vim muaj cov xwm txheej tsis zoo thaum lub sijhawm kho 24 lub lis piam tau txo qis (10.6% vs 38.9%). (2) Aimovig kuj tau pom qhov ua tau zoo tshaj plaws, nrog rau feem ntau ntawm cov neeg mob uas txo cov hnub migraine (MMD) ib hlis tsawg kawg yog 50% (55.4% vs 31.2%). Cov txiaj ntsig zoo ntawm pab pawg Aimovig tau txhais ua kev txhim kho tseem ceeb hauv tus neeg mob lub neej zoo thiab kev ua haujlwm tsis zoo. Nyob rau hauv txoj kev tshawb no, kev nyab xeeb ntawm Aimovig zoo ib yam nrog cov kev tshawb fawb soj ntsuam yav dhau los.

Xib fwb Uwe Reuter, Tus Thawj Saib Xyuas Kev Kho Mob ntawm Charles University, tau hais tias: "HER-MES yog thawj qhov kev tshawb fawb los sib piv ncaj qha rau cov tshuaj tiv thaiv kab mob thiab cov molecules me me hauv kev tiv thaiv migraine. Cov txiaj ntsig zoo txhawb nqa Aimovig raws li kev nyab xeeb thiab kev tiv thaiv kab mob migraine. Los ntawm kev txhim kho kev noj tshuaj, lub neej zoo ntawm cov neeg mob migraine tuaj yeem txhim kho tau zoo."

Lykke Hinsch Gylvin, Tus Thawj Coj ntawm Ntiaj Teb Kev Kho Mob Franchise rau Novartis Pharma's Neurosciences, tau hais tias: "Cov txiaj ntsig los ntawm qhov kev tshawb fawb thawj zaug thiab tsuas yog taub hau qhia tau tias Aimovig tau txais txiaj ntsig zoo dua thiab ua tau zoo dua li topiramate, uas ntxiv pov thawj Tus nqi ntawm Aimovig rau cov neeg mob migraine. Peb txaus siab los txuas ntxiv rov xav txog kev kho mob migraine los ntawm kev muab kev nyab xeeb thiab kev tiv thaiv zoo rau cov neeg mob migraine. "

Aimovig yog lub ntiaj teb' thawj cov tshuaj migraine tsom rau calcitonin-related gene peptide (CGRP) lub hom phiaj pom zoo los ntawm Novartis thiab Amgen hauv Tebchaws Meskas. Amgen muaj cai ua lag luam tshwj xeeb hauv kev lag luam Nyij Pooj, thiab Novartis muaj cai ua lag luam tshwj xeeb hauv lwm qhov hauv ntiaj teb. Aimovig yog cov tshuaj tiv thaiv CGRP tshaj plaws hauv ntiaj teb. Txij li thaum nws pib, ntau tshaj 520,000 tus neeg mob tau raug tshuaj Aimovig.

Calcitonin-related gene peptide (CGRP) yog ib qho neuropeptide uas tau pom tias raug tso tawm thaum muaj mob migraine thiab suav tias yog qhov ua rau mob migraine. Tam sim no, CGRP thiab nws cov receptors tau dhau los ua lub hom phiaj nrov rau kev txhim kho cov tshuaj migraine.

Txog rau tam sim no, muaj 4 monoclonal antibody migraine kev kho mob uas tsom CGRP thiab nws cov receptors, uas yog: Amgen / Novartis Aimovig, Teva Ajovy, Eli Lilly Emgality, thiab Lingbei Vyepti (eptinezumab). Hais txog cov tshuaj, ob qho tib si Aimovig thiab Emgality tau txhaj tshuaj subcutaneously ib hlis ib zaug, Ajovy tuaj yeem txhaj tshuaj subcutaneously ib hlis ib zaug lossis ib zaug txhua 3 lub hlis, thiab Vyepti txhaj tshuaj txhua 3 lub hlis.

Lwm cov tuam txhab muag tshuaj tab tom tsim qhov ncauj CGRP receptor antagonists. Tam sim no ntawm kev ua lag luam yog AbbVie's Ubrelvy (ubrogepant) thiab Biohaven's Zydis ODT (rimeegpantntsiav tshuaj disintegrating qhov ncauj), ob tshuaj rau kev kho mob ntawm cov neeg laus migraine (nrog los yog tsis muaj aura). Thaum kawg ntawm lub Cuaj Hli xyoo no, AbbVie Qulipta (atogepant) tau pom zoo los ntawm US FDA ua thawj qhov ncauj CGRP receptor antagonist rau kev tiv thaiv kev kho mob migraine.