Nsonaazụ kacha elu sitere na Ọgwụgwọ nke Mgbaàmà Menopause

Astellas Pharma Inc. taa kwuputara nsonaazụ topline sitere na Phase 3 SKYLIGHT 4™ nnwale ụlọ ọgwụ na-enyocha nchekwa ogologo oge nke fezolinetant, ihe nyocha nke ọnụ na-abụghị nke homonụ a na-amụ maka ọgwụgwọ nke mgbaàmà vasomotor na-agafeghị oke na nke siri ike metụtara menopause (VMS) nke. ga-akwado ntinye ntinye akwụkwọ iwu n'ọdịnihu. VMS, nke a na-eji ọkụ ọkụ na-ekpo ọkụ (nke a na-akpọkwa ọkụ ọkụ) na/ma ọ bụ ọsụsọ abalị, bụ ihe mgbaàmà nke menopause.1,2      

SKYLIGHT 4 bụ ihe a na-achịkwaghị achịkwa, ebe a na-achịkwa, nke kpuru ìsì okpukpu abụọ n'ime ihe karịrị ụmụ nwanyị 3 na-enyocha nchekwa ogologo oge (izu 1,800) nke fezolinetant n'ime ụmụ nwanyị na-achọ ọgwụgwọ maka enyemaka nke VMS jikọtara na menopause. Ebumnuche bụ isi nke ọmụmụ ihe ahụ bụ inyocha mmetụta fezolinetant na ahụike endometrial yana nchekwa ogologo oge na nnabata nke fezolinetant. Emere isi ihe njedebe na-enyocha ahụike endometrial yana ọgwụgwọ a na-ahụkarị nke emergent adverse (TEAE) bụ isi ọwụwa na COVID-52, kwekọrọ na placebo. Data topline gara n'ihu mara profaịlụ nchekwa ogologo oge nke fezolinetant ma ga-eme ka ndekọ usoro nhazi n'ọdịnihu. A ga-edobe nsonaazụ zuru ezu maka mbipụta yana maka nyocha na nzukọ ahụike na-abịanụ.

"Dabere na nyocha mbụ anyị, anyị nwere obi ụtọ na nsonaazụ nke SKYLIGHT 4, bụ nke na-akọwapụta nchekwa ogologo oge nke fezolinetant," Nancy Martin, MD, PharmD, Vice President, Global Medical Head, Medical Specialties, Astellas kwuru. . "Site na data fezolinetant ndị a, anyị nwere olile anya na anyị ga-enwe ohere ịnye nhọrọ ọgwụgwọ nke mbụ na klas nke na-abụghị nke homonụ maka oke VMS siri ike metụtara menopause."

"A na-akọkarị ihe mgbaàmà Vasomotor dị ka ihe mgbaàmà kachasị njọ nke menopause, ma enwere ntakịrị ihe ọhụrụ na mpaghara ọgwụgwọ a," ka Genevieve Neal-Perry, MD, Ph.D., oche, Ụlọ Akwụkwọ UNC School of Medicine Department of Obstetrics na kwuru. Gynecology. "Enwere m obi ụtọ site n'ikike nke nhọrọ ọgwụgwọ ọhụrụ na-abụghị nke hormonal maka ụmụ nwanyị na-enwe oke VMS na-agafeghị oke na nke siri ike metụtara menopause."

Nchọpụta SKYLIGHT 4, yana nsonaazụ sitere na nnwale ụlọ ọgwụ abụọ dị mkpa, SKYLIGHT 3™ na SKYLIGHT 1™, ga-enye data ntọala maka ntinye usoro iwu na US na Europe.

Fezolinetant bụ onye na-anabata neurokinin-3 (NK3) nyocha. A na-enyocha nchekwa na arụmọrụ nke fezolinetant mana emebeghị ya. Ọ bụrụ na ndị na-ahụ maka nhazi kwadoro, fezolinetant ga-abụ onye mbụ na klaasị, nhọrọ ọgwụgwọ na-abụghị nke homonụ iji belata ugboro na ogo nke VMS jikọtara ya na menopause.