US FDA pom zoo AbbVie Qulipta: Thawj Qhov ncauj CGRP Receptor Antagonist Rau Kev Tiv Thaiv Kev Kho Mob Migraine!

AbbVie tsis ntev los no tshaj tawm tias US Food and Drug Administration (FDA) tau pom zoo Qulipta (atogepant) rau kev tiv thaiv kev kho mob episodic migraine (EM) rau cov neeg laus. Nws tsim nyog hais tias Qulipta yog thawj zaug thiab tsuas yog qhov ncauj qhov ncauj calcitonin gene-related peptide (CGRP) receptor antagonist (gepant) tsim tshwj xeeb rau kev tiv thaiv kev kho mob migraine, uas yuav muab cov neeg mob yooj yim, muaj kev nyab xeeb thiab muaj txiaj ntsig zoo tiv thaiv cov tshuaj tiv thaiv. noj ib hnub ib zaug.

Migraine yog ib hom kab mob nyuaj. Nws qhov pib feem ntau ua rau tus neeg mob tsis muaj peev xwm ua neej 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 autonomic. Cov tsos mob thiab qhov hnyav ntawm migraines txawv heev ntawm cov tib neeg. Migraine tawm tsam tuaj yeem ua rau muaj kev ntxhov siab, tab sis migraine yog ib yam kab mob kho tau.

Qulipta' cov khoom siv tshuaj nquag yog atogepant, uas yog qhov ncauj CGRP receptor antagonist tsim tshwj xeeb rau kev tiv thaiv kev kho mob migraine. CGRP thiab nws cov receptors tau qhia nyob rau hauv cov cheeb tsam ntawm lub paj hlwb muaj feem xyuam rau pathophysiology ntawm migraine. Cov kev tshawb fawb pom tau hais tias CGRP qib nce thaum lub sij hawm migraine tawm tsam, thiab xaiv CGRP receptor antagonists muaj kev kho mob rau migraine.

Cov qauv tshuaj atogepant

Qhov kev pom zoo no yog ua raws li cov ntaub ntawv kho mob muaj zog txhawb nqa. Qhov project tau ua tiav nyob rau hauv ze li ntawm 2500 tus neeg mob uas muaj mob migraine rau 4-14 hnub hauv ib lub hlis, thiab ntsuas qhov ua tau zoo, kev nyab xeeb thiab kev zam ntawm qhov ncauj Qulipta rau kev kho mob migraine tiv thaiv. Txoj haujlwm no suav nrog Theem 3 ADVANCE txoj kev tshawb fawb tseem ceeb, Kev kawm tseem ceeb theem 2b/3 (CGP-MD-01) thiab theem 3 txoj kev tshawb fawb txog kev nyab xeeb mus sij hawm ntev.

Cov txiaj ntsig 12-lub lim tiam ntawm ADVANCE txoj kev tshawb fawb tau luam tawm hauv phau ntawv xov xwm kho mob thoob ntiaj teb" New England Journal of Medicine" (NIAM). Lub npe ntawm tsab xov xwm yog: Atogepant rau Kev Tiv Thaiv Kev Kho Mob Migraine. Cov ntaub ntawv qhia tau hais tias thaum lub sijhawm kho mob 12 lub lis piam, piv nrog cov placebo, tag nrho peb koob tshuaj (10mg, 30mg, 60mg) ntawm Qulipta yuav suav nrog qhov tseem ceeb, kev kho mob muaj txiaj ntsig, sai thiab txo qis hauv qhov nruab nrab ntawm cov hnub migraine hauv ib hlis (Txo ntau yam: 50% -100%), tshwj xeeb tshaj yog nyob rau hauv thawj 1-4 lub lis piam, qhov kev txo qis tseem ceeb tau pom. Tsis tas li ntawd, ob koob tshuaj siab (30mg, 60mg) tau pom tias muaj kev txhim kho tseem ceeb hauv tag nrho rau qhov kawg thib ob.

Hauv thaj chaw ntawm migraine, AbbVie yog muag BOTOX (Botox®, botulinum toxin A, onabotulinumtoxinA) thiab Ubrelvy (ubrogepant). Ntawm lawv, BOTOX yog thawj cov tshuaj tiv thaiv tau pom zoo los ntawm FDA rau cov neeg laus mob migraine, thiab Ubrelvy yog thawj qhov ncauj CGRP receptor antagonist (gepant) pom zoo los ntawm FDA rau cov neeg laus mob migraine (nrog lossis tsis muaj aura) kho mob. Qhov kev pom zoo ntawm Qulipta ua rau AbbVie tsuas yog lub tuam txhab tshuaj uas muaj 3 tshuaj los kho tag nrho cov kab mob migraine.

Dr. Michael Severino, Tus Lwm Thawj Coj thiab Thawj Tswj Hwm ntawm AbbVie, tau hais tias: “Muaj lab tus neeg mob yuav tsis tuaj yeem ua haujlwm tau ob peb hnub txhua lub hlis vim muaj mob migraine. Nrog kev tswj hwm qhov ncauj ib hnub ib zaug, Qulipta tuaj yeem txo qis migraine txhua hli. Hnub pab cov neeg mob. Peb zoo siab tias tam sim no AbbVie yog lub tuam txhab tshuaj nkaus xwb muab 3 cov khoom lag luam rau tag nrho cov kev kho mob migraine, suav nrog kev tiv thaiv kev kho mob migraine thiab episodic migraine, thiab kev kho mob ntawm migraine tawm tsam."

ADVANCE txoj kev kawm' cov ntsiab lus tseem ceeb kawg (Image source: NEJM)

ADVANCE yog ntau lub chaw, randomized, ob-dig muag, placebo-tswj, sib npaug-paj pawg theem 3 kev sim tsim los ntsuas kev ua tau zoo, kev nyab xeeb thiab kev ua siab ntev ntawm qhov ncauj atogepant hauv kev tiv thaiv migraine. Tag nrho ntawm 910 tus neeg mob tau muab faib ua 4 pawg kho mob, nrog 3 koob tshuaj (10mg, 30mg, 60mg) ntawm atogepant thiab placebo, hais lus ib hnub ib zaug. Kev tshuaj xyuas kev ua tau zoo yog raws li kev hloov kho lub hom phiaj-rau-kho (mITT) cov pej xeem ntawm 873 tus neeg mob.

Lub ntsiab lus kawg yog qhov kev hloov pauv ntawm qhov nruab nrab ntawm cov hnub migraine hauv ib hlis piv rau cov hauv paus hauv lub sijhawm kho 12 lub lis piam. Cov ntaub ntawv qhia tau hais tias tag nrho cov tshuaj atogepant tau mus txog qhov kawg ntawm qhov kawg, thiab qhov nruab nrab tus naj npawb ntawm migraine hnub hauv ib lub hlis tau txo qis dua piv nrog cov placebo. Cov 10mg / 30mg / 60mg atogepant pawg txo los ntawm 3.7 / 3.9 / 4.2 hnub, thiab pawg placebo txo ​​los ntawm 2.5 hnub (piv nrog cov placebo pab pawg rau tag nrho cov koob tshuaj, p<>

Thaum lub sij hawm kho mob 12 lub lis piam, qhov kev qhia ua ntej, ntau qhov kev tswj hwm qhov kawg ntawm qhov kawg ntawm cov txiaj ntsig suav nrog:

—— Ib hnub mob taub hau nruab nrab ib hlis: 10mg / 30mg / 60mg atogepant pawg tau txo qis los ntawm 3.9 (baseline 8.4), 4.0 (baseline 8.8), 4.2 (baseline 9.0) hnub, raws li, pawg placebo txo ​​los ntawm 2.5 hnub (baseline 8.4 hnub. ) (Piv nrog cov placebo pawg hauv txhua pawg koob tshuaj, p<>

—— Qhov nruab nrab ntawm cov hnub ntawm kev siv tshuaj mob hnyav hauv ib hlis: 10mg / 30mg / 60mg piv nrog cov pab pawg hauv paus atogepant txo los ntawm 3.7 / 3.7 / 3.9 hnub, raws li, pawg placebo txo ​​los ntawm 2.4 hnub (tag nrho cov koob tshuaj piv nrog cov pab pawg placebo, p<>

—— Qhov feem pua ​​​​ntawm cov neeg mob uas muaj hnub migraine txhua hli txo los ntawm ≥50%: Thaum lub sijhawm kho 12 lub lis piam, 55.6% / 58.7% / 60.8% ntawm cov neeg mob hauv 10mg / 30mg / 60mg atogepant pawg poob ≥50%, thiab qhov feem pua ​​​​ntawm cov neeg mob hauv cov placebo pab pawg tau mus txog tus qauv Nws yog 29.0% (tag nrho cov koob tshuaj piv nrog cov placebo pawg, p<>

—— Migraine-cov lus nug tshwj xeeb ntawm lub neej zoo version 2.1 (MSQ v2.1) lub luag haujlwm kev txwv kev txwv qhov qhab nia: hauv 12 lub lis piam, piv nrog cov placebo pab pawg, 10mg / 30mg / 60mg atogepant pawg tau txhim kho zoo (9.9 ntsiab lus, 10.1 cov ntsiab lus, 10.8 ntsiab lus; tag nrho cov koob tshuaj piv nrog cov placebo pawg, p<>

——AIM-D txhua hnub kev ua ub ua no cov qhab nia nyob rau hauv qhov nruab nrab txhua hli migraine chaw muag mis nyuj: Piv nrog rau cov placebo pab pawg, nws tau pom tias qhov nruab nrab txhua hli AIM-D txhua hnub cov qhab nia ntawm pawg 30mg thiab 60mg pawg tau nce ntau. 30mg pawg yog -2.5 ntsiab lus (p=0.0005), 60mg pawg yog -3.3 ntsiab lus (p<>

—— Zoo ib yam li kev ua haujlwm hauv kev ua haujlwm niaj hnub, qhov kev raug mob ntawm lub cev hauv AIM-D cov qhab nia qhia tau tias piv nrog cov pab pawg placebo, pawg 30 mg thiab 60 mg atogepant muaj kev txhim kho ntau dua, thiab 30 mg pawg muaj kev txhim kho ntau ntawm- 2.0 (p=0.0021), qhov kev txhim kho ntau ntawm 60mg pawg yog -2.5 (p=0.0002).

Nyob rau hauv txoj kev tshawb no, tag nrho cov koob tshuaj ntawm atogepant tau zoo zam. Feem ntau (≥5%) cov xwm txheej tsis zoo uas tau tshaj tawm hauv tsawg kawg ib pab pawg neeg kho mob yog cem quav (6.9-7.7% hauv txhua pab pawg, 0.5% hauv pawg placebo), xeev siab (4.4-6.1% hauv txhua pab pawg, placebo. 1.8% hauv pawg koob tshuaj), kab mob ua pa sab saud (3.9-5.7% hauv txhua pab pawg, 4.5% hauv pawg placebo). Feem ntau ntawm cem quav, xeev siab, thiab kab mob ua pa sab sauv yog me me los yog nruab nrab ntawm qhov hnyav thiab tsis ua rau txiav tawm.