Astellas Pharma Inc. ayaa maanta ku dhawaaqday natiijooyinka ugu sarreeya ee Wajiga 3 SKYLIGHT 4™ tijaabada caafimaad ee lagu baarayo badbaadada muddada dheer ee fezolinetant, baaritaan afka ah, xarun aan hormoon ahayn oo lagu baranayo daaweynta calaamadaha vasomotor dhexdhexaad ah ama daran ee la xidhiidha menopause (VMS) waxay taageeri doontaa soo gudbinta sharciyeynta mustaqbalka. VMS, oo lagu garto nalal kulul (oo sidoo kale loo yaqaanno kulaylka kulul) iyo/ama dhididka habeenkii, waa calaamadaha caadiga ah ee menopause.1,2

SKYLIGHT 4 waa tijaabo caafimaad oo la kala soocay, la xakameeyey, laba-indho la'aan Wajiga 3 tijaabo caafimaad oo ka badan 1,800 haween ah oo baaraya badbaadada muddada dheer (52-usbuuc) ee fezolinetant ee haweenka raadinaya daaweynta gargaarka VMS ee la xiriirta menopause. Ujeeddooyinka aasaasiga ah ee daraasadda ayaa ahaa in la qiimeeyo saameynta fezolinetant ee caafimaadka endometrial iyo badbaadada muddada dheer iyo dulqaadka fezolinetant. Meesha ugu dambeysa ee qiimeynta caafimaadka endometrial waa la gaarey iyo daawaynta ugu badan ee dhacdooyinka xun ee degdega ah (TEAE) waxay ahaayeen madax xanuun iyo COVID-19, oo waafaqsan placebo. Xogta safka sare waxay si dheeraad ah u tilmaameysaa astaanta badbaadada muddada-dheer ee fezolinetant waxayna ku wargelin doontaa galitaanka sharciyeynta mustaqbalka. Natiijooyin faahfaahsan ayaa loo soo gudbin doonaa daabacaadda iyo tixgelinta shirarka caafimaadka ee soo socda.

"Iyada oo lagu saleynayo qiimeyntayada bilowga ah, waxaan ku faraxsanahay natiijada SKYLIGHT 4, kaas oo sii tilmaamaya badbaadada muddada dheer ee fezolinetant," ayuu yiri Nancy Martin, MD, PharmD, Madaxweyne kuxigeenka, Madaxa Caafimaadka Caalamiga ah, Takhasusyada Caafimaadka, Astellas . "Xogtan fezolinetant, waxaan ku rajo weynahay inaan heli doono fursad aan ku bixino fasalka koowaad, doorashada daawaynta aan hormoonka ahayn ee VMS dhexdhexaad ah ama daran ee la xiriirta menopause."

"Calaamadaha Vasomotor waxaa inta badan lagu soo warramey inay yihiin calaamadaha ugu dhibka badan ee menopause, haddana waxaa jiray wax yar oo cusub oo ku saabsan aaggan daaweynta," ayuu yiri Genevieve Neal-Perry, MD, Ph.D., Guddoomiyaha, UNC School of Medicine Department of Obstetrics iyo Cilmiga haweenka "Waxaan ku faraxsanahay suurtagalnimada ikhtiyaarka daawaynta cusub ee aan hormoonnada ahayn ee haweenka la kulma VMS dhexdhexaad ah ama daran oo la xidhiidha menopause."

Natiijooyinka SKYLIGHT 4, oo ay weheliso natiijooyinka laba tijaabo oo tijaabo ah oo waji 3 ah, SKYLIGHT 1™ iyo SKYLIGHT 2™, ayaa bixin doona xogta aasaasiga ah ee soo gudbinta sharciyeynta ee Maraykanka iyo Yurub.

Fezolinetant waa neurokinin-3 (NK3) oo ka soo horjeeda soo-dhoweeyaha baarista ee xulashada. Badbaadada iyo waxtarka fezolinetant ayaa ku socda baaritaan lamana xaqiijin. Haddii ay ansixiyaan mas'uuliyiinta sharciyeynta, fezolinetant waxay noqon doontaa fasalka koowaad, ikhtiyaar daawaynta aan hormoonka ahayn si loo yareeyo inta jeer iyo darnaanta VMS ee la xiriirta menopause.

MAXAA LAGU QAADAYAA MAQAALKAN:

SKYLIGHT 4 is a randomized, placebo-controlled, double-blind Phase 3 clinical trial in over 1,800 women investigating the long-term (52-week) safety of fezolinetant in women seeking treatment for relief of VMS associated with menopause.
today announced topline results from the Phase 3 SKYLIGHT 4™ clinical trial investigating the long-term safety of fezolinetant, an investigational oral, nonhormonal compound being studied for the treatment of moderate to severe vasomotor symptoms associated with menopause (VMS) which will support future regulatory filing submissions.
The SKYLIGHT 4 findings, along with the results from two pivotal Phase 3 clinical trials, SKYLIGHT 1™ and SKYLIGHT 2™, will provide the foundational data for regulatory submissions in the U.