Ingantattun Bayanai don Rigakafin Maganin Ciwon Ciwon Ciwon Kaji

Nazarin Pivotal Phase 3 yana kimanta kafara a cikin manya marasa lafiya tare da ƙaura na yau da kullun ya sadu da ƙarshen ƙarshen ƙarshen ƙididdiga daga tushe a cikin kwanakin ƙaura na kowane wata idan aka kwatanta da placebo a duk tsawon lokacin magani na 12-week.

AbbVie a yau ya sanar da cewa gwajin PROGRESS na Mataki na 3 yana kimanta atogepant (QULIPTA™ a cikin Amurka), peptide mai alaka da kwayar halittar calcitonin na baka (CGRP) antagonist (gepant) don rigakafin rigakafin ciwon kai na yau da kullun a cikin manya, ya sadu da ƙarshen ƙarshen ƙarshensa na raguwar ƙididdiga daga tushe a cikin kwanakin ƙaura na kowane wata idan aka kwatanta da placebo. , don duka 60 MG sau ɗaya kowace rana (QD) da 30 MG sau biyu a kowace rana (BID), a duk tsawon lokacin jiyya na mako 12. Har ila yau, binciken ya nuna cewa jiyya tare da atogepant 60 mg QD da 30 MG BID ya haifar da ingantaccen ingantaccen ƙididdiga a duk ƙarshen ƙarshen sakandare bayan daidaitawa don kwatancen da yawa.

Wannan Mataki na 3, na duniya, bazuwar, makafi biyu, mai sarrafa wuribo, nazarin rukuni-rukuni ya kimanta inganci, aminci, da kuma jurewar maganganun maganganu don rigakafin rigakafin ciwon kai na yau da kullun, wanda shine cututtukan cututtukan jijiyoyin jiki inda marasa lafiya ke fama da ciwon kai. a kan 15 ko fiye da kwanaki a kowace wata don fiye da watanni uku, wanda a kalla kwanaki takwas a kowane wata yana da siffofi na ciwon kai na migraine.2,3 Jimlar marasa lafiya na 778 tare da akalla tarihin shekara guda na migraine na yau da kullum sun kasance bazuwar zuwa daya. na ƙungiyoyin jiyya guda uku don karɓar 60 mg QD na atogepant, 30 mg BID na atogepant, ko placebo.

An yi nazarin inganci ta amfani da ma'anoni daban-daban guda biyu na yawan majinyata bisa la'akari da ra'ayoyin hukumar gudanarwa a Amurka da Tarayyar Turai. Mayar da hankali kan Amurka, gyare-gyaren niyya don jiyya (mITT) yawan jama'a sun haɗa da marasa lafiya 755 tare da ƙimar eDiary bayanan ciwon kai da aka tattara yayin lokacin jiyya mai makafi biyu. Ƙididdigar ƙididdige ƙididdiga na ƙungiyar Tarayyar Turai da aka mayar da hankali kan kashe-jiyya (OTHE) sun haɗa da marasa lafiya 760 tare da ƙimar eDiary na ciwon kai da aka tattara a lokacin lokacin jiyya na makafi biyu da lokacin biyo baya.

A cikin makonni na 12, dangane da yawan mITT, marasa lafiya a cikin atogepant 60 mg QD da 30 MG BID magani makamai na binciken, sun sami raguwa na 6.88 da 7.46 na kowane wata migraine kwanaki, bi da bi, idan aka kwatanta da marasa lafiya a cikin placebo hannu, wanda sun sami raguwa na 5.05 na kowane wata migraine kwanakin (60 mg QD vs. placebo, p = 0.0009; 30 mg BID vs. placebo, p <0.0001, daidaitacce don kwatanta da yawa). Dangane da yawan OTHE, a cikin makonni na 12, marasa lafiya a cikin 60 mg QD da 30 MG BID na maganin maganin maganin maganin maganin maganin maganin maganin maganin maganin maganin maganin maganin maganin maganin maganin maganin maganin maganin maganin maganin maganin maganin maganin maganin maganin maganin maganin maganin maganin maganin maganin maganin maganin maganin maganin maganin maganin maganin maganin maganin maganin maganin maganin maganin maganin maganin maganin maganin maganin maganin maganin maganin maganin maganin maganin maganin maganin maganin maganin maganin maganin maganin maganin maganin maganin maganin maganin maganin maganin maganin maganin maganin maganin maganin maganin maganin maganin maganin maganin maganin maganin maganin maganin maganin maganin maganin maganin maganin maganin maganin maganin maganin maganin maganin maganin maganin maganin maganin maganin maganin maganin maganin maganin maganin maganin maganin maganin maganin maganin maganin maganin maganin maganin maganin . wanda ya sami raguwar kwanakin migraine na 6.75 na kowane wata (7.33 mg QD vs. placebo, p = 5.09; 60 mg BID vs. placebo, p = 0.0024, gyara don kwatancen da yawa).

Nazarin ya nuna cewa jiyya tare da atogepant 60 mg QD da 30 MG BID ya haifar da ingantaccen ingantaccen ƙididdiga a cikin duk ƙarshen ƙarshen sakandare don duka ƙididdigar ƙimar inganci.

Mahimmin mahimmin mahimmanci na biyu ya auna ma'auni na marasa lafiya wanda ya sami akalla 50% raguwa a cikin kwanakin migraine na kowane wata a cikin lokacin jiyya na 12-mako. Dangane da yawan mITT, gwajin ya nuna cewa 41.0% / 42.7% na marasa lafiya a cikin 60 mg QD da 30 MG BID atogepant makamai, bi da bi, sun sami aƙalla raguwar 50%, idan aka kwatanta da 26.0% na marasa lafiya a cikin hannun placebo. duk ƙungiyoyin kashi vs. placebo, p≤0.0009, gyara don kwatancen da yawa). Dangane da yawan OTHE, gwajin ya nuna cewa 40.1% / 42.1% na marasa lafiya a cikin 60 mg QD da 30 mg BID atogepant makamai, bi da bi, sun sami aƙalla raguwar 50%, idan aka kwatanta da 26.5% na marasa lafiya a cikin hannun placebo. duk ƙungiyoyin kashi vs. placebo, p≤0.0024, gyara don kwatancen da yawa). 1

Mahimmin bayanin lafiyar gaba ɗaya na binciken na 3 PROGRESS na Phase 5 ya kasance daidai da binciken aminci da aka lura a cikin binciken da aka yi a baya a cikin yawan ƙaura na episodic. Mafi yawan abubuwan da suka faru mara kyau da aka ruwaito tare da mitar ≥ 10.0% a cikin aƙalla hannu na maganin atogepant, kuma mafi girma fiye da placebo, sun kasance maƙarƙashiya (60% don atogepant 10.9 mg QD, 30% don atogepant 3.1 MG BID, da 9.6% don placebo) , da tashin zuciya (60% don atogepant 7.8 mg QD, 30% don atogepant 3.5 MG BID, da 2.7% don placebo). Yawancin abubuwan da suka faru na maƙarƙashiya da tashin zuciya sun kasance masu sauƙi ko matsakaici a cikin tsanani. Yawancin lokuta na maƙarƙashiya da tashin zuciya ba su haifar da dakatarwa ba. Ba a gano lamuran lafiyar hanta ba. Mummunan abubuwan da suka faru sun faru a cikin 60% na marasa lafiya tare da atogepant 1.6 MG QD da 30% na marasa lafiya da aka bi da su tare da atogepant 1.2 MG BID, idan aka kwatanta da XNUMX% na marasa lafiya tare da placebo. Babu ɗayan waɗannan abubuwan da suka faru na gaggawa na jiyya da aka tantance a matsayin jiyya mai alaƙa da mai binciken.

"AbbVie yana da kusan shekaru 12 na gwaninta wajen magance ciwon kai na yau da kullum, cuta mai lalacewa. Mun san cewa babu marasa lafiya na migraine guda biyu da suka yi kama da juna, don haka yana da mahimmanci ga ma'aikatan kiwon lafiya su sami zaɓuɓɓukan magani iri-iri, "in ji Michael Severino, MD, mataimakin shugaban kasa da shugaban kasa, AbbVie. "Wadannan bayanai da ƙaddamar da ƙa'idodin ƙa'ida sun tabbatar da ƙaddamar da mu ga babban fayil ɗin ƙaura don taimakawa fiye da mutane biliyan ɗaya a duk duniya waɗanda ke fama da ƙaura. Muna sa ran ɗaukar matakai na gaba don yuwuwar faɗaɗa amfani da atogepant a cikin Amurka don haɗawa da rigakafin rigakafin ciwon kai a cikin manya, da yin aiki tare da hukumomin gudanarwa a duniya kan ƙarin ƙaddamarwa. "

Wadannan bayanan suna ginawa akan sakamakon binciken na 3 ADVANCE na Phase 4, wanda yayi la'akari da atogepant don rigakafin rigakafin ciwon kai na episodic.3 Babban mahimmanci na binciken 12 ADVANCE na farko ya kasance raguwa mai mahimmanci a cikin kwanakin migraine na wata-wata a duk tsawon lokacin magani na XNUMX-mako idan aka kwatanta. ku placebo.

Dangane da sakamakon gwaji na 3 CIGABA DA KYAUTA a cikin ƙaura na yau da kullun, AbbVie yana niyyar ƙaddamar da ƙarin Sabuwar Drug Application (sNDA) tare da Hukumar Abinci da Magunguna ta Amurka don faɗaɗa amfani da atogepant don haɗawa da rigakafin rigakafin ƙaura. Bugu da ƙari, sakamakon binciken daga gwajin PROGRESS na Phase 3, tare da bayanan gwaji na Phase 3 ADVANCE, a cikin ƙaura na episodic, zai zama tushen tushen ƙaddamarwa na gaba a duniya. Ba a yarda da amfani da atogepant don rigakafin ciwon kai na yau da kullun a cikin Amurka ba kuma hukumomin tsaro ba su kimanta amincinsa da ingancin sa ba. Amfani da atogepant don rigakafin rigakafin ciwon kai na episodic da ƙaura na yau da kullun a wajen Amurka ba a yarda da shi ba kuma hukumomin tsaro ba su kimanta amincinsa da ingancinsa ba.