Imiphumela Ephambili Evela Ekwelapheni Izimpawu Zokunqamuka kokuya esikhathini

I-Astellas Pharma Inc. namuhla imemezele imiphumela ehamba phambili evela ocwaningweni lomtholampilo lweSigaba 3 SKYLIGHT 4™ oluphenya ukuphepha kwesikhathi eside kwe-fezolinetant, inhlanganisela yocwaningo yomlomo, engeyona ihomoni ecwaningwayo ukuze zelashwe izimpawu ze-vasomotor ezimaphakathi kuya kwezinzima ezihlobene nokunqamuka kokuya esikhathini (VMS) izosekela ukuhanjiswa kwamafayela okulawula okuzayo. I-VMS, ebonakala ngokuvutha (okubizwa nangokuthi ukushisa okushisayo) kanye/noma ukujuluka ebusuku, izimpawu ezivamile zokunqamuka kokuya esikhathini.1,2      

I-SKYLIGHT 4 ukuhlolwa komtholampilo okungahleliwe, okulawulwa yi-placebo, okuphuphutheke kabili kweSigaba 3 kwabesifazane abangaphezu kuka-1,800 abaphenya ukuphepha kwesikhathi eside (amaviki angama-52) kwe-fezolinetant kwabesifazane abafuna ukwelashelwa ukukhululeka kwe-VMS okuhambisana nokunqamuka kokuya esikhathini. Izinjongo eziyinhloko zocwaningo kwakuwukuhlola umphumela we-fezolinetant empilweni ye-endometrial kanye nokuphepha nokubekezelelana kwesikhathi eside kwe-fezolinetant. Isiphetho esiyinhloko sokuhlola impilo ye-endometrial safinyelelwa futhi izehlakalo ezivame kakhulu zokwelashwa eziphuthumayo (TEAE) kwakuyikhanda elibuhlungu kanye ne-COVID-19, ehambisana ne-placebo. Idatha ye-topline iphinde ibonise iphrofayili yokuphepha yesikhathi eside ye-fezolinetant futhi izokwazisa ukugcwaliswa kokulawula kwesikhathi esizayo. Imiphumela enemininingwane izothunyelwa ukuze ishicilelwe futhi icatshangelwe emihlanganweni yezokwelapha ezayo.

"Ngokusekelwe ekuhloleni kwethu kokuqala, sijabule ngomphumela wocwaningo lwe-SKYLIGHT 4, oluphinde lubonise ukuphepha kwesikhathi eside kwe-fezolinetant," kusho uNancy Martin, MD, PharmD, Vice President, Global Medical Head, Medical Specialties, Astellas. . “Ngale datha ye-fezolinetant, sinethemba lokuthi sizoba nethuba lokuletha inketho yokwelapha esezingeni lokuqala, engeyona eye-hormone ye-VMS emaphakathi kuya kokuqina ehambisana nokunqamuka kokuya esikhathini.”

"Izimpawu ze-Vasomotor zivame ukubikwa njengezimpawu ezikhathazayo kakhulu zokunqamuka kokuya esikhathini, nokho kube nokusha okuncane kakhulu kule ndawo yokwelapha," kusho uGenevieve Neal-Perry, MD, Ph.D., Usihlalo, UNC School of Medicine Department of Obstetrics and I-gynecology. “Ngijabulile ngokuba nokwenzeka kwenketho entsha yokwelashwa okungezona ama-hormone kwabesifazane abahlangabezana ne-VMS emaphakathi kuya kokuqina ehambisana nokunqamuka kokuya esikhathini.”

Okutholwe yi-SKYLIGHT 4, kanye nemiphumela evela ezinhlolweni ezimbili ezibalulekile zeSigaba sesi-3 zomtholampilo, i-SKYLIGHT 1™ kanye ne-SKYLIGHT 2™, kuzohlinzeka ngedatha eyisisekelo yokuthunyelwa kokulawula e-US naseYurophu.

I-Fezolinetant ingumphikisi wamamukeli we-neurokinin-3 (NK3) ophenywayo. Ukuphepha nokusebenza ngempumelelo kwe-fezolinetant kuyaphenywa futhi akukasungulwa. Uma igunyazwa iziphathimandla ezilawulayo, i-fezolinetant ingaba inketho yokwelapha yezinga lokuqala, engekho amahomoni ukuze kwehliswe imvamisa nokuqina kwe-VMS ehambisana nokunqamuka kokuya esikhathini.