AbbVie qhov ncauj CGRP receptor antagonist atogepant tau ua tiav qib III kev tiv thaiv tus mob taub!

AbbVie tau tshaj tawm tsis ntev los no tias Theem III ADVANCE kev sim tshuaj xyuas qhov tsis muaj zog rau kev mob taub hau tau mus txog nws qhov kawg. Cov ntaub ntawv pom tau tias thaum 12-lub lim tiam kho mob sijhawm, piv nrog cov placebo, txhua koob (10mg, 30mg, 60mg) ntawm atogepant cuam tshuam txo qis nruab nrab hli nruab hnub los ntawm theem pib. Ib qho ntxiv, ob qhov koob txhaj tshuaj loj (30mg, 60mg) qhia tau hais tias muaj kev txhim kho zoo nyob rau hauv tag nrho rau qhov kawg. Raws li cov txiaj ntsig no, nrog rau yav dhau los ua tau zoo Theem 2/3 cov txiaj ntsig kev xeem, AbbVie npaj yuav xa cov ntaub ntawv thov tsis raug cai hauv Tebchaws Meskas thiab lwm lub tebchaws. Cov ntaub ntawv tiav tiav yuav tshaj tawm hauv kev sib tham kev kho mob thiab / lossis luam tawm nyob rau hauv phau ntawv journal neeg zoo.

Atogepant yog qhov ncauj calcitonin gene-ntsig txog peptide (CGRP) receptor antagonist (gepant), tsim tshwj xeeb rau kev tiv thaiv kev kho mob rau mob taub hau. CGRP thiab nws cov chaw txais tau qhia nyob rau thaj chaw ntawm lub paj hlwb cuam tshuam nrog pathophysiology ntawm migraine. Cov kev tshawb fawb pom tau tias qib CGRP nce ntxiv thaum lub caij mob migraine, thiab xaiv CGRP receptor antagonists muaj kev cuam tshuam hauv chaw kho mob rau mob taub hau.

Hauv thaj teb ntawm migraine, AbbVie yog muag BOTOX (Botox®, botulinum toxin A, onabotulinumtoxinA) thiab Ubrelvy (ubrogepant). Ntawm lawv, BOTOX yog thawj qhov kev tiv thaiv tshuaj rau cov neeg laus muaj mob migraine tau pom zoo los ntawm US FDA, thiab Ubrelvy yog thawj qhov ncauj CGRP receptor antagonist (gepant) pom zoo los ntawm FDA rau cov neeg laus muaj migraine (nrog lossis tsis muaj aura) Kev kho mob hnyav.

Thomas J. Hudson, MD, laus lwm thawj coj thiab tus thawj coj tshawb fawb ntawm AbbVie Kev Tshawb Fawb thiab Kev Loj Hlob tau hais tias: “Kev tawm tsam kev mob taub hau tuaj yeem ua rau poob qis, tab sis kev mob taub hau yog hom mob uas kho tau. Raws li cov txiaj ntsig ntawm kev sim no, peb lub hom phiaj yog muab txoj kev tiv thaiv kev nyab xeeb thiab muaj txiaj ntsig zoo uas muab rau cov neeg mob thiab cov kws kho mob tau yooj yim, ib zaug ib hnub noj tshuaj qhov ncauj uas ua haujlwm los ntawm thaiv cov hlab ntsws CGRP thiab tiv thaiv kev mob qog."

Atogepant tshuaj qauv (duab los ntawm: genome.jp)

Hais txog qhov tseem ceeb Theem III ADVANCE sim:

Qhov no yog ntau lub ntsej muag, muaj kev soj ntsuam, muab ob sab dig muag, tso tshuaj tso rau hauv ib pawg, thaum sib tw ua ib pawg III mus soj ntsuam qhov ua tau zoo, kev nyab xeeb thiab kev pom zoo ntawm qhov ncauj atogepant hauv kev tiv thaiv kev mob taub hau. Tag nrho ntawm 910 tus neeg mob tau muab faib ua 4 pawg kho mob, 3 koob tshuaj (10mg, 30mg, 60mg) ntawm atogepant thiab placebo, qhov ncauj ib hnub ib zaug. Qhov kev ntsuas tau zoo tau raws li kev hloov pauv lub hom phiaj-rau-kho (mITT) cov pej xeem ntawm 873 tus neeg mob.

Lub hauv paus xaus yog qhov hloov ntawm tus naj npawb nruab nrab ntawm hnub migraine ib hlis los ntawm lub hauv paus thaum lub sijhawm kho 12-lub lim tiam. Cov ntaub ntawv tau qhia tias txhua pawg atogepant koob tshuaj tiv thaiv tau mus txog qhov pib qhov kawg, thiab tus naj npawb nruab nrab ntawm hnub migraine ib hlis tau tsawg zuj zus piv nrog placebo. 10mg / 30mg / 60mg atogepant pawg txo los ntawm 3.69 / 3.. 86 / 4.2 hnub, thiab cov placebo pawg txo los ntawm 2.48 hnub (piv nrog cov placebo pab pawg hauv txhua pawg koob tshuaj, p≤0.0001).

Qhov tseem ceeb theem ob kawg ntsuas qhov kev sib piv ntawm cov neeg mob uas muaj tsawg kawg 50% txo hauv cov hnub mob migraine ib hlis nyob rau lub sijhawm kho 12-lub lim tiam. Cov ntaub ntawv qhia tau hais tias 55.6% / 58.7% / 60.8% ntawm 10mg / 30mg / 60mg atogepant pawg tau raug txo los ntawm tsawg kawg 50%, thiab qhov sib piv ntawm cov neeg mob hauv cov pawg placebo yog 29.0% (piv rau cov placebo pawg hauv txhua koob pawg, p≤ 0.0001).

Lwm qhov kawg ntawm cov kev ntsuas thaum lub sijhawm 12-lub lis piam muaj xws li: hnub mob taub hau ib hlis ib hlis, ib hlis ib hlis ib hnub kev siv tshuaj, qhov nruab nrab txhua hnub kev ua tau zoo hauv kev ua haujlwm dias dias kev ua tsis taus (AIM-D), thiab lub cev raug mob. cov qhab nia los ntawm Qhov kev hloov pauv los ntawm lub hauv paus, thiab kev hloov pauv los ntawm lub hauv paus hauv Migraine-Qhia Txog Kev Zoo ntawm Lub Neej (MSQ) lub luag haujlwm txwv kev txwv tsis pub ua haujlwm nyob rau lub limtiam 12. Kev ntsuas pom tias 30 mg thiab 60 mg koob pawg tau muaj cov kev txhim kho tseem ceeb hauv tag nrho cov kev ua tiav, thaum 10 mg koob tshuaj pab pawg tau muaj kev txhim kho zoo nyob hauv 4 ntawm 6 qhov xaus kawg.

Hauv kev hais txog kev nyab xeeb, tsis muaj kev pheej hmoo tshiab muaj kev nyab xeeb piv rau kev nyab xeeb tau pom hauv kev sim ua ntej soj ntsuam atogepant. Cov kev mob hnyav tshwm sim hauv 0.9 cov neeg mob hauv 10 mg koob tshuaj pab pawg thiab 0.9% hauv pawg placebo. Tsis muaj qhov tshwm sim tsis zoo tshwm sim hauv pawg 30 mg koob tshuaj thiab 60 mg koob pawg. Tsawg kawg ntawm ib pawg atogepant kho mob, qhov tshwm sim tsis zoo tshaj plaws uas muaj ntau zaus ntawm ≥5% thiab siab dua cov placebo yog cem quav (6.9-7.7% hauv txhua pawg tshuaj, 0.5% hauv pawg placebo), xeev siab (4.4 nyob rau hauv txhua pawg koob tshuaj -6.1%, 1.8% hauv cov placebo pawg) thiab cov kab mob ua pa siab (3.9-5.7% hauv txhua pawg koob tshuaj thiab 4.5% hauv pawg placebo). Feem ntau ntawm cem quav, xeev siab thiab sab sauv txoj hlab nqus tau mob me me lossis mob nyhav thiab tsis ua rau muaj kev tsis ua haujlwm ntxiv. Tsis muaj teeb meem rau daim siab pom nyob hauv qhov kev sim no.

Hais txog 2/3 CGP-MD-01 kev kawm:

Txoj kev kawm no tau soj ntsuam cov kev ua tau zoo, kev nyab xeeb thiab kev tiv thaiv qhov ncauj ntawm qhov ncauj ua tsis tau. Cov ntaub ntawv qhia tau hais tias txhua pawg kho mob ntawm atogepant tau mus txog qhov chaw pib lub ntsiab. Lub sijhawm 12 lub lis piam kho mob, piv nrog cov placebo, qhov nruab nrab ntawm hnub migraine ib hlis tau txo qis piv nrog cov hauv paus (10mg QD vs placebo, p=0.0236; 30mg QD vs placebo P=0.0390; 60mg QD vs placebo, p=0.0390; 30mg BID vs placebo, p=0.0034; 60mg BID vs placebo, p=0.0031). Cov kev tshawb fawb tau tso rau lub Rau Hli 2018.