Axsome Therapeutics, Inc. ayaa maanta ku dhawaaqday in shirkaddu ay ka heshay Warqad Jawaab ah oo Dhameystiran (CRL) Maamulka Cuntada iyo Dawooyinka ee Maraykanka (FDA) oo ku saabsan Codsiga Cusub ee Dawooyinka (NDA) ee AXS-07 ee daaweynta degdega ah ee xanuunka dhanjafka. CRL ma aysan aqoonsan ama soo kicin wax walaac ah oo ku saabsan waxtarka bukaan-socodka ama xogta badbaadada ee NDA, iyo FDA ma aysan codsan wax tijaabo caafimaad oo cusub si ay u taageerto oggolaanshaha AXS-07.
Sababaha ugu muhiimsan ee lagu sheegay CRL waxay la xiriiraan tixgalinta kimistariga, wax soo saarka, iyo kontaroolada (CMC). CRL waxay aqoonsatay baahida loo qabo xogta CMC ee dheeraadka ah ee la xiriirta wax soo saarka daawada iyo habka wax soo saarka. Axsome wuxuu aaminsan yahay in arrimaha lagu soo qaaday CRL ay yihiin kuwo wax laga qaban karo oo ay doonayaan inay ku bixiyaan wakhtiga suurtagalka ah ee dib u soo gudbinta ka dib la tashi lala yeesho FDA.
"Waa hadafkeena inaan la shaqeyno FDA si aan si buuxda u fahamno oo aan si waafi ah wax uga qabno faallooyinkooda, si aan u samayn karno daawadan cusub ee muhiimka ah ee loogu talagalay bukaanada qaba xanuunka dhanjafka sida ugu dhakhsaha badan," ayuu yiri Herriot Tabuteau, MD, Madaxa Sare ee Axsome. . "Oggolaanshaha AXS-07 waxay bixinaysaa ikhtiyaarka daawaynta badan ee farsamo-yaqaannada badan ee loo baahan yahay malaayiinta qof ee la nool xaaladdan neerfaha daciifka ah."
NDA waxaa taageera natiijooyin ka yimid laba weji 3 randomized, double-indhon, tijaabooyin la xakameeyey ee AXS-07 ee daawaynta degdega ah ee xanuunka dhanjafka, MOMENTUM iyo INTERCEPT tijaabooyinka, taas oo muujisay tirakoob ahaan ciribtirka xanuunka dhanjafka leh AXS-07 marka la barbar dhigo placebo iyo kontaroolada firfircoon.
In ka badan 37 milyan oo Maraykan ah ayaa la ildaran xanuunka dhanjafka sida ay sheegtay Xarumaha Xakamaynta Cudurrada, waana sababta ugu weyn ee naafanimada u ah xanuunada neerfaha ee Maraykanka sida ay qabto American Migraine Foundation. Migraine waxaa lagu gartaa weerarrada soo noqnoqda ee garaaca wadnaha, badanaa daran oo naafo ah madax xanuun lallabo, iyo dareenka iftiinka iyo codka. Waxaa lagu qiyaasaa in madax xanuunka dhanjafka uu si toos ah u leeyahay $78 bilyan (tusaale booqashooyinka dhakhtarka, daawooyinka) iyo si dadban (tusaale shaqo seegtay, wax soo saar luntay) sanad walba gudaha Maraykanka [1]. Sahan la daabacay oo ku saabsan xanuunka dhanjafka ayaa tilmaamaya in in ka badan 70% aysan si buuxda ugu qanacsanayn daaweyntooda hadda, in ku dhawaad 80% ay isku dayi doonaan daaweyn cusub, iyo in ay rabaan daweyn u shaqeeya si dhakhso ah, si joogto ah, oo keena soo noqoshada calaamadaha.
MAXAA LAGU QAADAYAA MAQAALKAN:
- The CRL did not identify or raise any concerns about the clinical efficacy or safety data in the NDA, and the FDA did not request any new clinical trials to support the approval of AXS-07.
- Over 37 million Americans suffer from migraine according to the Centers for Disease Control, and it is the leading cause of disability among neurological disorders in the United States according to the American Migraine Foundation.
- NDA waxaa taageera natiijooyin ka yimid laba weji 3 randomized, double-indhon, tijaabooyin la xakameeyey ee AXS-07 ee daawaynta degdega ah ee xanuunka dhanjafka, MOMENTUM iyo INTERCEPT tijaabooyinka, taas oo muujisay tirakoob ahaan ciribtirka xanuunka dhanjafka leh AXS-07 marka la barbar dhigo placebo iyo kontaroolada firfircoon.
