Dacwoodaha Bristol Myers Squibb Company (BMS) ayaa dacwad ka gudbiyay eedaysanaha Xspray Pharma AB ee Degmada New Jersey Arbacadii. Dacwadda ku xadgudubka shatiga ayaa doonaysa inay ka hortagto in Eedaysanayaashu sameeyaan oo ay iibiyaan noocyada guud ee daawada Sprycel ee Dacwoodaha.
Sprycel waxaa loogu talagalay daaweynta dadka waaweyn iyo carruurta lagu ogaado noocyada kala duwan ee leukemia. Dacwoodayaashu waxay haystaan laba shati, shati '725 ah iyo shati '103 ah (shati ku habboon), oo cinwaankeedu yahay "Hababka loogu talagalay diyaarinta 2-aminothiazole-5-aromatic carboxamides oo ah inhibitors kinase." Shatiyada waxaa la soo saaray 2009 iyo 2014 siday u kala horreeyaan. Marka laga soo tago shatiga su'aasha laga qabo, dacwoodayaashu waxay sidoo kale leeyihiin codsi cusub oo daawo ah (NDA) oo loogu talagalay daawo afka laga qaato.
Sida ku cad dacwadda, Xspray waxay FDA u gudbisay heshiis aan shaacinayn kaas oo ay ku doonayaan ogolaansho ay ku soo saaraan oo ay ku suuqgeeyaan nooc guud oo Sprycel ah. Waxyaabaha kale ee ay ka mid yihiin, Xspray waxay la xiriirtay dacwoodayaasha waxayna ku wargelisay in sheegashada shatiga ee la isku haysto ay tahay mid aan sax ahayn ama aysan ku xadgudbin badeecadaha mustaqbalka ee eedaysanayaasha.
Warqadda Xspray ee loo diray dacwoodayaasha ayaa siisay marin qarsoodi ah qaybo ka mid ah Xspray NDA, laakiin ma siin dacwoodayaashu inay galaan faylka ugu muhiimsan ee daroogada. Dacwoodayaashu ma haystaan fursado ay ku galaan faylasha daroogada ee ugu muhiimsan, taas oo caqabad ku ah "awooddooda ay ku eegaan macluumaadka la xiriira falanqayntooda xadgudubyada," ayay cabashadu leedahay.
Cabashadu waxay ku andacoonaysaa in Xspray uu jebiyay ugu yaraan hal sheegasho oo ka mid ah mid kasta oo ka mid ah shatiyada la isweydiinayo. Intaa waxaa dheer, Dacwoodayaashu waxay sharraxayaan in Eedaysanayaashu ay ku dhawaaqeen ujeedkooda ah inay soo saaraan oo ay suuq geeyaan alaabadooda NDA isla markiiba ka dib markii FDA ay ansixisay, taas oo Dacwoodayaashu ay ku doodayaan inay noqon doonto jebinta shatiyada kor ku xusan.
BMS waxay ku doodday in haddii eedaysanayaasha aan laga hor istaagin inay sii wadaan jebinta shatiyada su'aasha laga qabo, ay la kulmi doonaan "waxyeelo weyn oo aan la soo kaban karin". Cabashadu waxay taxaysaa laba dacwadood oo ku saabsan jebinta shatiga. Dacwoodayaashu waxay raadinayaan go'aan wanaagsan oo ku saabsan dacwad kasta, amar lagu joojinayo jebinta kale, amar lagu hubinayo in alaabada NDA ee eedaysanayaasha aan la soo saari doonin ka hor intaysan dhicin shatiga su'aasha laga qabo, gargaar lacageed haddii eedaysanayaashu ay xayaysiiyaan alaabadooda NDA, iyo waxyaabo kaloo badan.
Waqtiga boostada: Abriil-12-2023