Kugwiritsa Ntchito Mankhwala Kwatsopano kwa Chithandizo Chachikulu cha Migraine

A GWIRITSANI KwaulereKutulutsidwa 5 | eTurboNews | | eTN
Avatar ya Linda Hohnholz
Written by Linda Hohnholz

Axsome Therapeutics, Inc. lero yalengeza kuti Kampani yalandira Kalata Yonse Yankho (CRL) kuchokera ku US Food and Drug Administration (FDA) ponena za New Drug Application (NDA) ya AXS-07 yochizira mutu waching'alang'ala. A CRL sanazindikire kapena kudandaula za momwe chipatala chikuyendera kapena chitetezo cha data mu NDA, ndipo a FDA sanapemphe mayesero atsopano azachipatala kuti agwirizane ndi kuvomereza kwa AXS-07.

Zifukwa zazikulu zomwe zaperekedwa mu CRL zikukhudza chemistry, Production, and Controls (CMC). CRL idazindikira kufunikira kwa data yowonjezera ya CMC yokhudzana ndi mankhwala ndi njira zopangira. Axsome akukhulupirira kuti zovuta zomwe zatulutsidwa mu CRL zitha kuthetsedwa ndipo akufuna kupereka nthawi yoti atumizidwenso pambuyo pokambirana ndi FDA.

"Ndicholinga chathu kuti tigwire ntchito ndi FDA kuti timvetse bwino ndikuyankha mokwanira ndemanga zawo, kuti tithe kupanga mankhwala atsopano ofunikirawa kwa odwala omwe ali ndi migraine mwamsanga," adatero Herriot Tabuteau, MD, Chief Executive Officer wa Axsome. . "Kuvomerezedwa kwa AXS-07 kungapereke njira yatsopano yochizira matenda osiyanasiyana omwe akufunika kwambiri kwa anthu mamiliyoni ambiri omwe ali ndi vuto la minyewa lofooketsali."

NDA imathandizidwa ndi zotsatira za magawo awiri a Phase 3, mayesero opangidwa mwachisawawa, akhungu awiri, olamulidwa a AXS-07 pa chithandizo chamankhwala cha migraine, mayesero a MOMENTUM ndi INTERCEPT, omwe adawonetsa kuthetsa kwakukulu kwa ululu wa migraine ndi AXS-07 poyerekeza ndi placebo. ndi zowongolera zogwira ntchito.

Anthu opitilira 37 miliyoni aku America amadwala mutu waching'alang'ala malinga ndi Centers for Disease Control, ndipo ndichomwe chimayambitsa kulumala pakati pa matenda amisala ku United States malinga ndi American Migraine Foundation. Migraine imadziwika ndi kugunda mobwerezabwereza kwa kugunda, komwe nthawi zambiri kumakhala koopsa komanso kolepheretsa kupweteka kwamutu komwe kumayenderana ndi nseru, komanso kumva kuwala kapena phokoso. Akuti mutu waching'alang'ala umapanga $78 biliyoni mwachindunji (mwachitsanzo, kupita kwa dokotala, kumwa mankhwala) ndi njira zina (mwachitsanzo, kuphonya ntchito, kutayika kwa ntchito) kumawononga chaka chilichonse ku United States [1]. Kafukufuku wofalitsidwa wa odwala migraine amasonyeza kuti oposa 70% sakukhutira mokwanira ndi chithandizo chawo chamakono, kuti pafupifupi 80% angayese mankhwala atsopano, ndipo amafuna chithandizo chamankhwala chomwe chimagwira ntchito mofulumira, mosasinthasintha, ndipo chimapangitsa kuti zizindikirozo zisabwererenso.

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Linda Hohnholz

Mkonzi wamkulu kwa eTurboNews zochokera ku eTN HQ.

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