Nā ʻikepili maikaʻi no ka mālama ʻana i ka mālama ʻana i ka maʻi ʻeha maʻamau

ʻO ke aʻo ʻana ʻo Pivotal Phase 3 e loiloi ana i ke kalahala i nā poʻe maʻi maʻi me ka migraine maʻi e hālāwai me ka hopena mua o ka hōʻemi koʻikoʻi helu mai ka helu ʻana i nā lā migraine maʻamau i hoʻohālikelike ʻia me ka placebo ma waena o ka manawa mālama 12-wiki.

Ua hoʻolaha ʻo AbbVie i kēia lā i ka hoʻāʻo ʻana o ka Phase 3 PROGRESS e loiloi ana i ka atogepant (QULIPTA™ ma ʻAmelika Hui Pū ʻIa), he peptide e pili ana i ka calcitonin gene-related peptide (CGRP) receptor antagonist (gepant) no ka mālama pale ʻana i ka migraine maʻi i nā pākeke, ua hālāwai me kāna kumu mua o ka hōʻemi nui ʻana mai ka helu kumu i nā lā migraine mau mahina i hoʻohālikelike ʻia me ka placebo , no ka 60 mg hoʻokahi manawa i kēlā me kēia lā (QD) a me 30 mg ʻelua i kēlā me kēia lā (BID), ma waena o ka manawa mālama 12-wiki. Ua hōʻike pū ʻia ka haʻawina ʻo ka mālama ʻana me ka atogepant 60 mg QD a me 30 mg BID ka hopena i nā hoʻomaikaʻi koʻikoʻi i ka helu helu ma nā helu hope a pau ma hope o ka hoʻoponopono ʻana no nā hoʻohālikelike lehulehu.

ʻO kēia Phase 3, honua, randomized, double-blind, placebo-controlled, parallel-group study i loiloi i ka pono, palekana, a me ka ʻae ʻana o ka atogepant waha no ka mālama ʻana i ka migraine maʻi, kahi maʻi neurological debilitating kahi e ʻike ai nā poʻe maʻi i ke poʻo. ma ka 15 aʻoi aʻe paha nā lā o kēlā me kēia mahina no nā mahinaʻoi aʻe ma mua oʻekolu mahina, aia ma kahi oʻewalu mau lā o ka mahina i loaʻa nā hiʻohiʻona o ka migraine headache.2,3 ʻO ka nui o nā maʻi 778 me ka liʻiliʻi o hoʻokahi makahiki o ka moʻolelo o ka migraine maʻamau i randomized i hoʻokahi. o ʻekolu pūʻulu lapaʻau e loaʻa iā 60 mg QD o atogepant, 30 mg BID o atogepant, a i ʻole placebo.

Ua kālailai ʻia ka maikaʻi me ka hoʻohana ʻana i ʻelua wehewehe ʻokoʻa ʻē aʻe o ka heluna kanaka maʻi e pili ana i ka manaʻo o ka ʻoihana hoʻoponopono i ka United States a me ʻEulopa. ʻO ka heluna kanaka o ka United States-focused, modified intent-to-treat (mITT) i loaʻa i nā maʻi 755 me ka ʻikepili eDiary headache i hōʻiliʻili ʻia i ka wā o ka lāʻau lapaʻau makapō ʻelua. ʻO ka European Union-focused off-treatment hypothetical estimand (OTHE) ka heluna kanaka he 760 mau maʻi me ka headache evaluable data eDiary i hōʻiliʻili ʻia i loko o ka manawa mālama makapō ʻelua a me ka manawa hahai.

Ma nā pule he 12, e pili ana i ka heluna mITT, nā mea maʻi i ka atogepant 60 mg QD a me 30 mg BID lāʻau lapaʻau o ka haʻawina, ua ʻike i ka emi ʻana o 6.88 a me 7.46 mau mahina migraine mau lā, i hoʻohālikelike ʻia me nā mea maʻi i ka lima placebo, ka mea. uaʻike i ka emiʻana o 5.05 mau mahina migraine mau lā (60 mg QD vs. placebo, p = 0.0009; 30 mg BID vs. placebo, p <0.0001, hoʻololiʻia no nā hoʻohālikelike he nui). Ma muli o ka heluna kanaka OTHE, ma nā wiki he 12, ʻo nā maʻi i ka 60 mg QD a me 30 mg BID o nā lima lāʻau atogepant o ke aʻo ʻana, ua ʻike i ka emi ʻana o 6.75 a me 7.33 mau mahina migraine mau lā, i hoʻohālikelike ʻia me nā mea maʻi i ka lima placebo. ka mea i ʻike i ka emi ʻana o 5.09 mau mahina migraine mau lā (60 mg QD vs. placebo, p = 0.0024; 30 mg BID vs. placebo, p = 0.0001, hoʻoponopono ʻia no nā hoʻohālikelike lehulehu).

Ua hōʻike ʻia ka haʻawina ʻo ka mālama ʻana me ka atogepant 60 mg QD a me 30 mg BID ka hopena i nā hoʻomaikaʻi koʻikoʻi i ka helu helu ma nā wahi hope lua no nā heluna helu helu efficacy.

Ua ana ʻia kahi helu hope koʻikoʻi i ka hapa o nā maʻi i loaʻa i ka liʻiliʻi he 50% ka emi ʻana o nā lā migraine mahina ma waena o ka manawa mālama 12-week. Ma muli o ka heluna kanaka mITT, ua hōʻike ka hoʻokolokolo ʻana he 41.0% / 42.7% o nā mea maʻi i ka 60 mg QD a me 30 mg BID atogepant lima, kēlā me kēia, ua loaʻa i ka liʻiliʻi he 50% hoʻemi, hoʻohālikelike ʻia me 26.0% o nā mea maʻi i ka lima placebo ( ʻO nā hui āpau a pau me ka placebo, p≤0.0009, hoʻoponopono ʻia no nā hoʻohālikelike lehulehu). Ma muli o ka heluna kanaka OTHE, ua hōʻike ka hoʻāʻo ʻana he 40.1% / 42.1% o nā mea maʻi i ka 60 mg QD a me 30 mg BID atogepant lima, kēlā me kēia, ua loaʻa i ka liʻiliʻi he 50% hoʻemi, hoʻohālikelike ʻia me 26.5% o nā maʻi i ka lima placebo ( ʻO nā hui āpau a pau me ka placebo, p≤0.0024, hoʻoponopono ʻia no nā hoʻohālikelike lehulehu). 1

ʻO ka hōʻike palekana holoʻokoʻa o ka haʻawina Phase 3 PROGRESS i kūlike me nā ʻike palekana i ʻike ʻia ma nā haʻawina mua i kahi heluna episodic migraine. ʻO nā hanana ʻino maʻamau i hōʻike ʻia me ka alapine ≥ 5% i ka liʻiliʻi o hoʻokahi lima lapaʻau atogepant, a ʻoi aku ka nui ma mua o placebo, ʻo ia ka constipation (10.0% no ka atogepant 60 mg QD, 10.9% no ka atogepant 30 mg BID, a me 3.1% no kahi placebo) , a me ka nausea (9.6% no atogepant 60 mg QD, 7.8% no atogepant 30 mg BID, a me 3.5% no placebo). ʻO ka hapa nui o nā hanana o ka constipation a me ka nausea he haʻahaʻa a haʻahaʻa paha i ka paʻakikī. ʻO ka hapa nui o ka constipation a me ka nausea ʻaʻole i alakaʻi i ka hoʻopau ʻana. ʻAʻole i ʻike ʻia nā pilikia palekana hepatic. Ua loaʻa nā hanana ʻino koʻikoʻi ma 2.7% o nā mea maʻi me ka atogepant 60 mg QD a me 1.6% o nā maʻi i mālama ʻia me ka atogepant 30 mg BID, hoʻohālikelike ʻia me 1.2% o nā maʻi me kahi placebo. ʻAʻole i helu ʻia kekahi o kēia mau hanana ʻino e like me ka mālama ʻana e ka mea noiʻi.

"Ua kokoke ʻo AbbVie i 12 mau makahiki o ka ʻike i ka mālama ʻana i ka migraine maʻi, kahi maʻi hoʻonāwaliwali. Uaʻike mākouʻaʻoleʻelua mau maʻi migraine i like, no laila, he mea nui i nā mea mālama ola ke loaʻa nāʻano lapaʻau likeʻole, "wahi a Michael Severino, MD, ka pelekikena hope a me ka pelekikena, AbbVie. "ʻO kēia mau ʻikepili a me nā hoʻouna hoʻoponopono e kali nei e hoʻopaʻa i kā mākou kūpaʻa i kā mākou alakaʻi migraine portfolio e kōkua i ka ʻoi aku ma mua o hoʻokahi piliona kānaka e noho nei me ka migraine. Ke kakali nei mākou i ka hana ʻana i nā hana aʻe e hiki ai ke hoʻonui i ka hoʻohana ʻana i ka atogepant i ʻAmelika Hui Pū ʻIa e hoʻokomo i ka mālama pale ʻana i ka migraine maʻi i nā pākeke, a me ka hana pū ʻana me nā keʻena hoʻoponopono ma ke ao holoʻokoʻa i nā hoʻouna hou.

Kūkulu ʻia kēia mau ʻikepili ma ka hopena o ka haʻawina ʻo Phase 3 ADVANCE, i loiloi i ka atogepant no ka mālama pale ʻana i ka episodic migraine. i placebo.

Ma muli o nā hopena o ka hoʻāʻo ʻana o ka pae 3 PROGRESS i ka migraine maʻi, manaʻo ʻo AbbVie e hoʻouna i kahi noi hou lāʻau lapaʻau hou (sNDA) me ka US Food and Drug Administration no ka hoʻonui ʻana i ka atogepant e komo i ka mālama pale ʻana i ka migraine mau. Eia kekahi, ʻo nā hopena noiʻi mai ka hoʻāʻo ʻana o ka Phase 3 PROGRESS, me ka ʻikepili hoʻāʻo ʻo Phase 3 ADVANCE, i ka episodic migraine, e lilo i kumu no ka hoʻouna ʻana i nā kānāwai e hiki mai ana ma ka honua. ʻAʻole ʻae ʻia ka hoʻohana ʻana i ka atogepant no ka mālama ʻana i ka migraine maʻi ma United States a ʻaʻole i loiloi ʻia kona palekana a me ka pono e nā luna hoʻoponopono. ʻAʻole ʻae ʻia ka hoʻohana ʻana i ka atogepant no ka mālama ʻana i ka episodic migraine a me ka migraine mau ma waho o ʻAmelika Hui Pū ʻIa a ʻaʻole i loiloi ʻia kona palekana a me ka pono e nā luna hoʻoponopono.