Positive Data Yekudzivirira Kurapa KweChisingaperi Migraine

Pivotal Phase 3 yekuongorora kuongorora kuyananisira muvarwere vakura vane migraine isingagumi inosangana nemagumo ekupedzisira ekuderedza kwakakosha kubva kune yekutanga mukati memazuva emwedzi migraine kana ichienzaniswa ne placebo mukati me12-vhiki yekurapa nguva.

AbbVie nhasi yakazivisa kuti Phase 3 PROGRESS kuyedza kuongorora atogepant (QULIPTA™ muUnited States), an oral calcitonin gene-related peptide (CGRP) receptor antagonist (gepant) yekudzivirira kurapwa kwechisingaperi migraine muvakuru, yakasangana nemagumo ayo ekutanga ekuderedza kwakakosha kuderedzwa kubva padanho rekutanga mazuva emwedzi migraine achienzaniswa ne placebo. , kune ese 60 mg kamwe pazuva (QD) uye 30 mg kaviri zuva nezuva (BID) doses, mukati me12-vhiki yekurapa nguva. Chidzidzo chacho chakaratidzawo kuti kurapwa neatogepant 60 mg QD uye 30 mg BID yakaguma nekuvandudzwa kwehuwandu mumagumo ose echipiri mushure mekugadzirisa kwekuenzanisa kwakawanda.

Iyi Phase 3, yepasi rose, yakasarudzika, yakapetwa kaviri-mapofu, placebo-inodzorwa, parallel-boka kudzidza yakaongorora kugona, kuchengetedzwa, uye kushivirira kweoral atogepant yekudzivirira kurapwa kwekusingaperi migraine, inova inokanganisa tsinga chirwere apo varwere vanonzwa musoro uchiitika. pa 15 kana kupfuura mazuva pamwedzi kwemwedzi inopfuura mitatu, iyo inenge mazuva masere pamwedzi ine zviratidzo zvemigraine musoro. yemapoka matatu ekurapa kuti agamuchire 2,3 mg QD yeatogepant, 778 mg BID yeatogepant, kana placebo.

Kubudirira kwakaongororwa pachishandiswa tsananguro mbiri dzakati siyanei dzehuwandu hwevarwere zvichibva pamhinduro yesangano rekutonga muUnited States neEuropean Union. IUnited States-yakatarisa, yakagadziridzwa chinangwa-ku-kurapa (mITT) vanhu vaisanganisira varwere ve755 vane inoongororwa musoro eDiary data yakaunganidzwa panguva yekurapa kaviri-bofu. IEuropean Union-yakatarisana ne-off-treatment hypothetical estimand (OTHE) huwandu hwevanhu vaisanganisira varwere ve760 vane inoongororwa musoro eDiary data yakaunganidzwa panguva yekurapwa kwemapofu maviri uye nguva yekutevera.

Mukati memavhiki e12, zvichienderana nehuwandu hwemITT, varwere vari muatogepant 60 mg QD uye 30 mg BID kurapwa maoko echidzidzo, vakawana kuderera kwe6.88 uye 7.46 pamwedzi migraine mazuva, zvichienderana, zvichienzaniswa nevarwere vari muruoko rwe placebo, avo. akawana kuderera kwe5.05 pamwedzi migraine mazuva (60 mg QD vs. placebo, p = 0.0009; 30 mg BID vs. placebo, p <0.0001, yakagadziridzwa nokuda kwekuenzanisa kwakawanda). Kubva pahuwandu hweOTHE, mumasvondo e12, varwere vari mu60 mg QD uye 30 mg BID yeatogepant kurapwa maoko echidzidzo, vakawana kuderera kwe6.75 uye 7.33 pamwedzi migraine mazuva, zvichienderana, zvichienzaniswa nevarwere vari muruoko rwe placebo, uyo akawana kuderera kwe5.09 pamwedzi migraine mazuva (60 mg QD vs. placebo, p = 0.0024; 30 mg BID vs. placebo, p = 0.0001, yakagadziriswa kuenzanisa kwakawanda).

Chidzidzo chacho chakaratidza kuti kurapwa neatogepant 60 mg QD uye 30 mg BID kwakaguma nekuvandudzwa kwakakosha mumagumo ese echipiri kune ese ari maviri efficacy analysis populations.

Chinhu chakakosha chechipiri chekupedzisira chakayera chikamu chevarwere vakawana zvishoma kuderedzwa kwe50% mumazuva emwedzi migraine mazuva mukati me12-vhiki yekurapa nguva. Zvichienderana nehuwandu hwemITT, muedzo wakaratidza kuti 41.0%/42.7% yevarwere mu60 mg QD uye 30 mg BID atogepant maoko, zvakateerana, vakawana kuderedzwa kwe50%, zvichienzaniswa ne26.0% yevarwere vari muruoko rwe placebo. mapoka ose emadhora vs. placebo, p ≤0.0009, yakagadziridzwa kuti ienzaniswe kakawanda). Zvichienderana nehuwandu hweOTHE, muedzo wakaratidza kuti 40.1% / 42.1% yevarwere mu60 mg QD uye 30 mg BID atogepant maoko, maererano, vakawana zvishoma kuderedzwa kwe50%, zvichienzaniswa ne26.5% yevarwere vari muropa re placebo. mapoka ose emadhora vs. placebo, p ≤0.0024, yakagadziridzwa kuti ienzaniswe kakawanda). 1

Iyo yakazara chengetedzo nhoroondo yeChikamu 3 PROGRESS yekudzidza yaienderana nekuchengetedzwa kwakawanikwa muzvidzidzo zvekare mune episodic migraine vanhu. Zviitiko zvinowanzoitika zvakashata zvinoshumwa nehuwandu ≥ 5% mune imwechete atogepant kurapwa ruoko, uye yakakura kupfuura placebo, kwaiva kuvimbiswa (10.0% yeatogepant 60 mg QD, 10.9% yeatogepant 30 mg BID, uye 3.1% ye placebo) , uye kuda kurutsa (9.6% yeatogepant 60 mg QD, 7.8% yeatogepant 30 mg BID, uye 3.5% ye placebo). Zvizhinji zvezviitiko zvekuzvimba uye kusvotwa zvaive zvinyoro kana zvine mwero mukuomarara. Zviitiko zvakawanda zvekuvharwa uye kusvotwa hazvina kutungamira mukuregedzwa. Pakanga pasina nyaya dzekuchengetedza hepatic dzakaonekwa. Zviitiko zvakakomba zvakashata zvakaitika mu2.7% yevarwere vane atogepant 60 mg QD uye 1.6% yevarwere vakabatwa neatogepant 30 mg BID, zvichienzaniswa ne1.2% yevarwere vane placebo. Hapana chimwe cheizvi kurapa-zvichiitika zviitiko zvakashata zvakaongororwa sekurapa-kwakabatana nemuongorori.

“AbbVie ane makore anoda kusvika gumi nemaviri eruzivo rwekurapa chisingaperi migraine, chirwere chinopedza simba. Tinoziva kuti hapana varwere vaviri vane migraine vakafanana, saka zvakakosha kuti vatapi vehutano vave nemhando dzakasiyana-siyana dzokurapa, "akadaro Michael Severino, MD, vamiriri vesachigaro uye mutungamiri, AbbVie. "Idzi data uye zvakamirira kutumirwa kwemitemo zvinosimbisa kuzvipira kwedu kune yedu inotungamira migraine portfolio kubatsira vanhu vanopfuura bhiriyoni imwe pasirese vari kurarama nemigraine. Tinotarisira kutora matanho anotevera kuti awedzere kushandiswa kweatogepant muUnited States kuti ibatanidze kurapa kwechigarire migraine muvakuru, uye kushanda nemasangano anodzora pasi rose pane zvimwe zvinotumirwa. "

Iyi data inovaka pane Phase 3 ADVANCE yekudzidza mhinduro, iyo yakaongorora atogepant yekudzivirira kurapwa kwepisodic migraine.4 Mhedziso yekutanga yeChikamu 3 ADVANCE yekudzidza yakanga iri kuderedzwa kwakakosha kwehuwandu hwemazuva emwedzi wega wega migraine munguva yose ye12-vhiki yekurapa ichienzaniswa. kuti placebo.

Kubva pamigumisiro yechikamu 3 PROGRESS muedzo mukusingaperi migraine, AbbVie inotarisira kuendesa imwe yekuwedzera New Drug Application (sNDA) neU.S. Food and Drug Administration kuti iwedzere kushandiswa kweatogepant kusanganisa kurapa kwekudzivirira kwekusingaperi migraine. Pamusoro pezvo, mhedzisiro yekudzidza kubva kuChikamu 3 PROGRESS kuyedza, pamwe neiyo Phase 3 ADVANCE yekuyedza data, muepisodic migraine, ichaita hwaro hwekutumirwa kwekutonga kweramangwana pasi rose. Kushandiswa kweatogepant yekudzivirira kurapwa kwechisingaperi migraine muUnited States haina kubvumidzwa uye kuchengetedzwa kwayo uye kushanda kwayo hakuna kuongororwa nevakuru vekutonga. Kushandiswa kweatogepant yekudzivirira kurapwa kwe episodic migraine uye kusingaperi migraine kunze kweUnited States hakubvumirwi uye kuchengetedzwa kwayo uye kushanda kwayo hazvina kuongororwa nevane masimba.