I-Axsome Therapeutics, Inc. namuhla imemezele ukuthi Inkampani ithole Incwadi Yempendulo Ephelele (CRL) evela kwa-US Food and Drug Administration (FDA) mayelana ne-New Drug Application (NDA) yayo ye-AXS-07 yokwelashwa okunamandla kwe-migraine. I-CRL ayizange ihlonze noma iveze ukukhathazeka mayelana nokusebenza komtholampilo noma idatha yokuphepha ku-NDA, futhi i-FDA ayizange icele noma yiziphi izivivinyo zomtholampilo ezintsha ukuze isekele ukugunyazwa kwe-AXS-07.
Izizathu eziyinhloko ezinikezwe ku-CRL zihlobene nokucatshangelwa kwamakhemikhali, ukukhiqiza, nokulawula (CMC). I-CRL ihlonze isidingo sedatha eyengeziwe ye-CMC ephathelene nomkhiqizo wezidakamizwa kanye nenqubo yokukhiqiza. U-Axsome ukholelwa ukuthi izinkinga eziphakanyiswe ku-CRL ziyaxazululeka futhi uhlose ukunikeza isikhathi esingase sibe khona sokuthunyelwa kabusha ngemva kokubonisana ne-FDA.
"Kuwumgomo wethu ukusebenzisana ne-FDA ukuze siqonde ngokugcwele futhi sibhekane ngokwanele nokuphawula kwabo, ukuze sikwazi ukwenza lo muthi omusha obalulekile utholakale ezigulini ezine-migraine ngokushesha ngangokunokwenzeka," kusho u-Herriot Tabuteau, MD, i-Chief Executive Officer ye-Axsome. . "Ukugunyazwa kwe-AXS-07 kunganikeza inketho entsha yokwelapha edingeka kakhulu ezigidini zabantu abaphila nalesi simo esintengayo sezinzwa."
I-NDA isekelwa yimiphumela evela ezivivinyweni ezimbili zeSigaba 3 ezingahleliwe, ezingaboni kabili, ezilawulwayo ze-AXS-07 ekwelapheni okunamandla kwe-migraine, ukuhlolwa kwe-MOMENTUM kanye ne-INTERCEPT, okubonise ukuqedwa okuphawulekayo kobuhlungu be-migraine nge-AXS-07 uma kuqhathaniswa ne-placebo. nezilawuli ezisebenzayo.
Abantu baseMelika abangaphezu kwezigidi ezingu-37 bahlushwa i-migraine ngokusho kweCenters for Disease Control, futhi iyimbangela ehamba phambili yokukhubazeka phakathi kokuphazamiseka kwezinzwa e-United States ngokusho kwe-American Migraine Foundation. I-Migraine ibonakala ngokuhlaselwa okuphindaphindiwe kokushaya, ngokuvamile okubuhlungu nokukhubaza ubuhlungu bekhanda obuhambisana nokucanuzela kwenhliziyo, nokuzwela ukukhanya noma umsindo. Kulinganiselwa ukuthi i-migraine ibiza amaRandi ayizigidi eziyizinkulungwane ezingu-78 ngokuqondile (isb ukuvakasha kodokotela, imithi) kanye nokungaqondile (isib. ukuphuthelwa umsebenzi, ukulahlekelwa ukukhiqiza) kubiza unyaka ngamunye e-United States [1]. Ukuhlola okushicilelwe kwabaphethwe yi-migraine kubonisa ukuthi abangaphezu kuka-70% abanelisekile ngokugcwele ngokwelashwa kwabo kwamanje, ukuthi cishe amaphesenti angu-80 azozama ukwelashwa okusha, nokuthi afisa ukwelashwa okusebenza ngokushesha, okungaguquki, futhi kubangele ukuphindaphinda kwezimpawu ezincane.
LOKHO ONGAKUTHATHE KULESI SIHLOKO:
- 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.
- I-NDA isekelwa yimiphumela evela ezivivinyweni ezimbili zeSigaba 3 ezingahleliwe, ezingaboni kabili, ezilawulwayo ze-AXS-07 ekwelapheni okunamandla kwe-migraine, ukuhlolwa kwe-MOMENTUM kanye ne-INTERCEPT, okubonise ukuqedwa okuphawulekayo kobuhlungu be-migraine nge-AXS-07 uma kuqhathaniswa ne-placebo. nezilawuli ezisebenzayo.
