AbbVie atogepant: tiv thaiv kev kho mob paroxysmal migraine, siv tau thiab nyab xeeb! --- 1/2

AbbVie tsis ntev los no tshaj tawm tias 12-lub lim tiam cov txiaj ntsig ntawm Phase 3 ADVANCE kev sim tshuaj xyuas qhov ncauj ntawm qhov ncauj hais txog peptide (CGRP) receptor antagonist (gepant) atogepant tiv thaiv kev mob taub hau tau luam tawm hauv International Medical Journal" Phau ntawv Askiv Tshuaj Kho Mob (NEJM). Lub npe ntawm tsab xov xwm yog: Atogepant rau Kev Tiv Thaiv Kev Kho Mob Migraine.

Kev sim tau ua tiav hauv cov neeg laus uas tau ntsib cov txheej txheem rau mob taub hau ntev (EM). Tus naj npawb ntawm hnub mob taub hau tau ntsib los ntawm cov neeg mob tau tso npe yog 4-14 hnub hauv ib hlis. Thawj qhov txiaj ntsig tau pom tias thaum lub sijhawm kho mob 12-lub lim tiam, piv nrog cov placebo, txhua qhov koob tshuaj (10 mg, 30 mg, 60 mg hais lus ib hnub ib hnub) ntawm atogepant txheeb cais txo tus naj npawb nruab nrab ntawm cov mob taub hau ib hnub hauv ib hlis los ntawm qib pib . Hais txog qhov kawg ntawm qhov thib ob, piv nrog cov placebo, feem coob ntawm cov neeg mob kho nrog atogepant ntawm txhua qhov koob tshuaj txo tus naj npawb nruab nrab ntawm cov mob taub hau ib hnub hauv ib hlis los ntawm %50%. Ib qho ntxiv, ob qhov koob tshuaj loj (30mg, 60mg) atogepant tau qhia txog kev txhim kho tseem ceeb hauv txhua rau rau qhov ua ntej tau teev tseg, ntau qhov kev tswj hwm thib ob qhov kawg, suav nrog txo qis kev siv tshuaj hnyav thiab ntsuas kev ua haujlwm tsis zoo.

Atogepant yog qhov ncauj CGRP receptor antagonist (gepant), tam sim no tau tshuaj xyuas los ntawm Asmeskas FDA: nws tau siv rau cov neeg mob laus uas ua tau raws li cov txheej txheem rau mob taub hau (EM) txhawm rau tiv thaiv mob taub hau. FDA xav kom txiav txim siab txoj cai los ntawm qhov kawg ntawm peb lub hlis twg ntawm xyoo 2021. Yog pom zoo, atogepant yuav yog thawj zaug thiab tsuas yog qhov ncauj gepant tshwj xeeb tau tsim tshwj xeeb rau kev tiv thaiv kev kho mob episodic migraine (EM), thiab yuav muab cov neeg mob nrog yooj yim, nyab xeeb thiab muaj txiaj ntsig tiv thaiv kev kho mob uas tau noj ib hnub ib zaug. .

Michael Gold, tus lwm thawj coj ntawm kev txhim kho paj hlwb ntawm AbbVie, tau hais tias: "Ntau tus neeg nyob thoob plaws ntiaj teb ntsib teeb meem mob taub hau, uas ua rau lub nra hnyav rau cov neeg mob, cov saib xyuas thiab kev kho mob. Ntawm AbbVie, peb tau txiav txim siab Peb tau cog lus tias yuav txhawb txoj kev kho mob tshiab hauv kev mob taub hau txuas ntxiv. Cov ntaub ntawv no ntxiv dag zog rau peb txoj kev ntseeg siab rau atogepant uas yog qhov muaj peev xwm kho tau rau kev tiv thaiv mob taub hau."

Atogepant cov qauv tshuaj

Migraine yog ib yam kab mob ntev. Nws pib feem ntau ua rau tus neeg mob poob lub peev xwm nyob lossis ua haujlwm ib txwm muaj. Nws tuaj yeem suav nrog mob taub hau hnyav thiab cov tsos mob ntawm lub paj hlwb thiab tus kheej. Cov tsos mob thiab qhov hnyav ntawm migraines sib txawv ntawm cov tib neeg. Kev tawm tsam mob taub hau tuaj yeem ua rau tsis txaus ntseeg, tab sis mob taub hau yog ib yam kab mob kho tau.

Atogepant yog lub qhov ncauj calcitonin hais txog peptide (CGRP) receptor antagonist (gepant), tshwj xeeb tshaj yog tsim los tiv thaiv kev kho mob migraine. CGRP thiab nws cov receptors tau hais tawm hauv thaj chaw ntawm lub paj hlwb ntsig txog kab mob pathology ntawm migraine. Cov kev tshawb fawb tau qhia tias CGRP qib nce ntxiv thaum muaj mob migraine, thiab xaiv CGRP receptor antagonists muaj cov kev mob tshwm sim ntawm mob taub hau.

atogepant NDA yog ua raws cov ntaub ntawv kho mob muaj zog txhawb nqa. Txoj haujlwm tau ua tiav nyob rau ze li ntawm 2500 tus neeg mob migraine 4-14 hnub hauv ib hlis, thiab tshuaj xyuas qhov ua tau zoo, kev nyab xeeb thiab kev tiv taus ntawm qhov ncauj atogepant rau kev tiv thaiv kev mob taub hau. Txoj haujlwm suav nrog qhov tseem ceeb Phase 3 ADVANCE txoj kev kawm, tseem ceeb Phase 2b/3 kawm (CGP-MD-01) thiab Phase 3 kev nyab xeeb mus sij hawm ntev.