Zotsatira Zapamwamba za Kuchiza kwa Zizindikiro Zosiya Kusiya Kusamba

Astellas Pharma Inc. lero yalengeza zotsatira zapamwamba kuchokera ku mayeso achipatala a Phase 3 SKYLIGHT 4™ ofufuza zachitetezo chanthawi yayitali cha fezolinetant, mankhwala ofufuza pakamwa, osatulutsa mahomoni omwe akuphunziridwa kuti athe kuchiza zizindikiro zapakati kapena zazikulu za vasomotor zomwe zimagwirizanitsidwa ndi kusintha kwa thupi (VMS) imathandizira kutumizidwa kwamtsogolo kwamafayilo. VMS, yomwe imadziwika ndi kutentha kwa thupi (komwe kumatchedwanso kutentha kwamoto) ndi/kapena kutuluka thukuta usiku, ndi zizindikiro zofala za kusintha kwa thupi.1,2      

SKYLIGHT 4 ndi mayeso osasinthika, oyendetsedwa ndi placebo, akhungu awiri a Phase 3 mwa amayi opitilira 1,800 omwe amafufuza zachitetezo chanthawi yayitali (masabata 52) a fezolinetant mwa amayi omwe akufuna chithandizo cha VMS yokhudzana ndi kusintha kwa thupi. Zolinga zazikulu za phunziroli zinali kupenda zotsatira za fezolinetant pa thanzi la endometrial komanso chitetezo chanthawi yayitali komanso kulekerera kwa fezolinetant. Mapeto omaliza owunika thanzi la endometrial adakwaniritsidwa ndipo zodziwika bwino zachipatala (TEAE) zinali mutu ndi COVID-19, zogwirizana ndi placebo. Deta yam'mwambamwamba ikuwonetsanso mbiri yachitetezo cha nthawi yayitali ya fezolinetant ndipo idzadziwitsa zomwe zidzachitike m'tsogolomu. Zotsatira zatsatanetsatane zidzatumizidwa kuti zifalitsidwe ndikuganiziridwa pamisonkhano yachipatala yomwe ikubwera.

"Kutengera kuwunika kwathu koyambirira, ndife okondwa ndi zotsatira za kafukufuku wa SKYLIGHT 4, womwe ukuwonetsanso chitetezo chanthawi yayitali cha fezolinetant," adatero Nancy Martin, MD, PharmD, Wachiwiri kwa Purezidenti, Global Medical Head, Medical Specialties, Astellas. . "Ndi data ya fezolinetant iyi, tili ndi chiyembekezo kuti tikhala ndi mwayi wopereka chithandizo choyambirira, chopanda mahomoni cha VMS yocheperako kapena yovuta kwambiri yokhudzana ndi kusintha kwa thupi."

"Zizindikiro za Vasomotor nthawi zambiri zimanenedwa ngati zizindikiro zovutitsa kwambiri za kutha kwa thupi, komabe pakhala pali zatsopano zochepa kwambiri m'dera lochizirali," adatero Genevieve Neal-Perry, MD, Ph.D., Chair, UNC School of Medicine Department of Obstetrics and Gynecology. "Ndili wokondwa ndi kuthekera kwa njira yatsopano yochiritsira yopanda mahomoni kwa amayi omwe ali ndi VMS yapakati kapena yovuta kwambiri yokhudzana ndi kusintha kwa thupi."

Zomwe zapezedwa za SKYLIGHT 4, limodzi ndi zotsatira za mayeso achipatala ofunikira a Phase 3, SKYLIGHT 1™ ndi SKYLIGHT 2™, zipereka chidziwitso choyambira ku US ndi Europe.

Fezolinetant ndi wotsutsa wa neurokinin-3 (NK3) receptor antagonist. Chitetezo ndi mphamvu ya fezolinetant ikufufuzidwa ndipo sichinakhazikitsidwe. Ngati avomerezedwa ndi maulamuliro, fezolinetant ingakhale njira yoyamba, yopanda mahomoni kuti muchepetse kuchulukira komanso kuopsa kwa VMS komwe kumakhudzana ndi kusintha kwa thupi.