Mutsva Mushonga Wekushandisa weAcute Kurapa Migraine

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rakanyorwa Linda Hohnholz

Axsome Therapeutics, Inc. nhasi yakazivisa kuti Kambani yakagamuchira Tsamba Yemhinduro Yakakwana (CRL) kubva kuUS Food and Drug Administration (FDA) maererano neNew Drug Application (NDA) yeAXS-07 yekurapwa kwakanyanya kwemigraine. CRL haina kuona kana kusimudza chero zvainonetsa pamusoro pekushanda kwekiriniki kana kuchengetedza data muNDA, uye FDA haina kukumbira chero miyedzo mitsva yekiriniki kuti itsigire kubvumidzwa kweAXS-07.

Zvikonzero zvikuru zvakapihwa muCRL zvine chekuita nemakemikari, kugadzira, uye kutonga (CMC) kufunga. Iyo CRL yakaona kudiwa kweimwe CMC data ine chekuita nechigadzirwa chemishonga uye maitiro ekugadzira. Axsome anotenda kuti nyaya dzakasimudzwa muCRL dzinogadziriswa uye inotarisira kupa nguva yekumisikidzwa mushure mekubvunzana neFDA.

"Ndiyo chinangwa chedu kushanda neFDA kuti tinzwisise zvizere uye kugadzirisa zvakakwana zvavanotaura, kuitira kuti tigone kuita kuti mushonga uyu unokosha uwanike kune varwere vane migraine nokukurumidza sezvinobvira," akadaro Herriot Tabuteau, MD, Chief Executive Officer weAxsome. . "Kutenderwa kweAXS-07 kwaizopa nzira itsva inodiwa yakawanda yekurapa kumamiriyoni evanhu vari kurarama nechirwere ichi chinonetesa chetsinga."

Iyo NDA inotsigirwa nemhedzisiro kubva kune maviri Phase 3 randomized, kaviri-mapofu, controlled miedzo yeAXS-07 mukurapa kwakanyanya kwemigraine, iyo MOMENTUM uye INTERCEPT miedzo, iyo yakaratidza zvakanyanya kubviswa kwemigraine kurwadziwa neAXS-07 zvichienzaniswa ne placebo. uye mashandiro anoshanda.

Pamusoro pe37 mamiriyoni eAmerica anotambura nemigraine maererano neCenters for Disease Control, uye ndicho chikonzero chikuru chekuremara pakati pezvirwere zvetsinga muUnited States maererano neAmerican Migraine Foundation. Migraine inoratidzirwa nekudzokororwa kurwiswa kwekupuruzira, kazhinji kwakanyanya uye kuremadza marwadzo emusoro ane chekuita nekusvotwa, nekunzwa kuchiedza uye kana ruzha. Inofungidzirwa kuti migraine inotora $ 78 bhiriyoni zvakananga (semuenzaniso kushanya kwachiremba, mishonga) uye zvisina kunanga (semuenzaniso kurovha basa, kurasikirwa nekubudirira) inodhura gore rega rega muUnited States [1]. Ongororo yakabudiswa yevanorwara nemigraine inoratidza kuti vanopfuura 70% havasi kunyatsogutsikana nekurapa kwavo kwemazuva ano, kuti vanenge 80% vangaedza kurapa kutsva, uye kuti vanoda mishonga inoshanda nekukurumidza, nguva dzose, uye inoita kuti zviratidzo zvishoma zvidzoke zvakare.

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Avatar of Linda Hohnholz

Linda Hohnholz

Editor mukuru we eTurboNews yakavakirwa muTN HQ.

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