Yovant oral Relugolix, yon GnRH Récepteurs antagonis, siyifikativman redwi/ki pa gen doule nan ekzamen an!

Myovant syans se yon konpayi swen sante konsantre sou devlope terapi inovate redéfinir sante fanm yo ak swen kanse pwostat. Denyeman, konpayi an te anonse ke premye faz III etid la nan pwoje LESPRI a evalye relugolix tablet konpoze (relugolix 40 mg, estradiol 1,0 mg, norethisterone D' 0,5 mg) yo trete fanm ki gen doule endometriosis ki gen rapo te rive nan yon komen efikasite prensipal endpoint ak 6 kle endpoints segonde. Nan etid la, relugolix tablet konpoze yo te byen tolere, ki gen ladan dansite zo minimom pedi pandan 24 semen nan tretman.

Myovant te anonse tou ke nan yon etid klinik separe, dapre Hoogland Skouby evalyasyon an (not<5), relugolix="" compound="" tablets="" achieved="" 100%="" ovulation="" suppression="" in="" 67="" healthy="" women="" during="" the="" 84-day="" treatment="" period="" (="" score=""><5 points).="" in="" addition,="" 100%="" of="" women="" resume="" ovulation="" or="" menstruation="" after="" stopping="" treatment,="" with="" an="" average="" ovulation="" time="" of="" 23.5="">

Faz endometriosis Myovant nan III pwoje klinik LESPRI a gen ladan 2 transpote nasyonal, repete kle syans klinik (LESPRI 1, LESPRI 2), se evalye efikasite ak efikasite nan tablet konpoze relugolix nan tretman an nan fanm endometriosis ki gen rapo ak sekirite. Nan etid la, pasyan fi yo te owaza divize an twa gwoup, ki resevwa relugolix grenn tablet (yon fwa pa jou) pou 24 semen, relugolix Dwog sel (40 mg, yon fwa pa jou) pou 12 semen + relugolix grenn tablet (yon fwa pa jou) pou 12 semen, plasebo tretman pou semen 24. Fanm ki kalifye ki konplete syans 2 gen opotinite pou yo patisipe nan yon etid ekstansyon tretman aktif. Nan etid sa a, tout fanm te resevwa relugolix nan plizye tablet pou semen 80, ak peryod la tretman total ka rive nan semen 104. Etid la vize a evalye long tem sekirite ak soutni efikasite tretman.

Nan analiz la nan endpoint an komen prensipal nan etid la 2 LESPRI, 75,2% nan fanm nan relugolix gwoup la konprime konpoze ak 30,4% nan fanm nan gwoup la plasebo reyalize yon klinikman rediksyon ki gen sans nan Eg difisil (p<0.0001). for="" non-menstrual="" pelvic="" pain,="" 66.0%="" of="" women="" in="" the="" relugolix="" compound="" tablet="" group="" and="" 42.6%="" of="" women="" in="" the="" placebo="" group="" had="" a="" clinically="" significant="" reduction="" (p=""><0.0001). on="" average,="" on="" the="" 11-point="" (0-10)="" digital="" rating="" scale="" for="" dysmenorrhea,="" the="" dysmenorrhea="" numerical="" score="" of="" women="" in="" the="" relugolix="" treatment="" group="" decreased="" by="" 75.1%,="" from="" 7.2="" (severe="" pain)="" to="" 1.7="" points="" (mild="">

An plis, relugolix tablet konpoze yo te estatistik siyifikatif konpare ak plasebo an tem de 6 kle segonde endpoints a mezire nan semen 24, ki gen ladan: vle di Eg difisil ak chanjman nan doule an jeneral, ak Efe a nan doule sou aktivite chak jou (le li sevi avek aparey intra uterin Membranous sante estati-30 [EHP-30] mezi domen), yon pousantaj ki pi wo nan fanm pa itilize<0.0001), nonmenstrual="" pelvic="" pain="" (p="0.0012)" and="" intercourse="" difficulties="" (p="">

Nan etid la, relugolix tablet konpoze yo te byen tolere, ak pedi dansite ki nan bra minimom pandan peryod la 24 semen tretman. Ensidan an jeneral nan evenman negatif te sanble nan gwoup la relugolix konpoze, ak gwoup la plasebo (80,6% vs 75,0). 5,3% nan fanm nan relugolix gwoup la abandonnées konpoze ki gen menm tretman an akoz evenman negatif, konpare ak 3,9 nan gwoup la plasebo. Evenman ki pi komen yo ki te fet nan omwen 10% nan pasyan fi nan gwoup la konprime relugolix konpoze te maltet, nasopharyngitis, ak cho chale. Te gen 3 gwoses nan gwoup la konprime relugolix konpoze ak 5 gwoses nan gwoup la plasebo.

Linda Giudice, MD, yon pwofese pi popile nan syans repwodiksyon nan inivesite a nan California, san Francisco (UCSF), te di: "Endometriosis ka lakoz grav doule fizik ak emosyon pou anpil fanm ki bezwen nouvo tretman ki pa ap pwogrese apwopriye pou itilizasyon alontem. Ezole. Rezilta yo klinikman ki gen sans anonse jodi a yo tre ankouraje, espesyalman doz la menm nan relugolix tablet konpoze ki te reyalize amelyorasyon siyifikatif nan doule tou te montre bon tolerans, ki gen ladan pedi an mas ne pet. "

Lynn Seely, MD, CEO nan Myovant, te di: "baze sou faz sikse nou an, etid ranche fibwom, nou tre satisfe ak rezilta pozitif nan anket endometriosis faz III a, ki pote nou pi pre pou nou reyisi vizyon nou: pou pote fanm soufri nan men maladi sa yo yon Dwog yon fwa pa jou, yon grenn nan yon moman, Dwog sa a se yon grenn chak jou ki balans Nou gade pou pi devan pou pataje rezilta lot etid endometriosis nou an, LESPRI 1, pita sezon sa a. "

relugolix fomil estriktirel chimik (sous: medchemexpress.com) ak mekanis aksyon

Relugolix se yon yon fwa-chak jou, oral, koryal-Divilge omon (GnRH) récepteurs antagonis ki ka diminye ovarian estradiol pwodiksyon pa bloke resepte GnRH nan glann pitwiter, yon monn li te ye pou estimile kwasans lan nan ranche fibwom ak endometriosis. Anplis de sa, relugolix kapab tou empêcher pwodiksyon omon gason, yon omon ki ka ankouraje kwasans lan nan kanse pwostat.

Kounye a, Myovant ap devlope tablet konpoze relugolix nan trete ranche fibwom ak endometriosis. Anplis de sa, konpayi an ap devlope tou relugolix tablet Dwog sel (120mg, yon fwa pa jou) pou tretman an nan kanse avanse pwostat.

Nan mwa Mas nan ane sa a, Myovant soumet yon aplikasyon otorizasyon maketing (MAA) pou relugolix tablet konpoze nan ajans la nan medikaman Ewopeyen (EMA) pou tretman an nan modere nan sentom grav nan fanm ki gen ranche fibwom. Plan konpayi yo pou soumet yon nouvo aplikasyon sou Dwog (NDA) nan relugolix konpoze tablet nan FDA a nan Me ane sa a pou indications yo menm. De sentom ki pi komen nan ranche fibwom yo se lou ki ap senyen (HMB) ak doule. Si ou apwouve, tablet konpoze relugolix pral bay yon tretman yon sel-jou pou pasyan fi ak fibwom ranche. Jis denyeman, konpayi an te soumet yon nouvo aplikasyon pou Dwog pou relugolix tablet Dwog sel (120mg) nan FDA a pou tretman nan pasyan gason ak kanse avanse pwostat. Nan faz anket la EWO III, to a diminisyon nan relugolix nan tretman de kanse nan pwostat la te osi wo ke 96,7%, ki te siyifikativman pi bon pase leuprolide D'.

Relugolix te devlope pa Takeda, ak Myovant (yon konpayi ki te fome pa Roivant ak Takeda) jwenn yon lisans eksklizif mondyal nan mwa Jen 2016 eksepte Japon ak lot peyi Azyatik. Nan Japon, relugolix te apwouve nan mwa Janvye 2019 e li se commercialisés anba non an mak Relumina amelyore sentom sa yo ki te koze pa ranche fibwom: pedans, pi ba doule anbavant, pi ba doule tounen, ak anemi.

Aplikasyon an nan tablet relugolix konpoze pou tretman an nan ranche fibwom se ki baze sou done yo efikasite ak sekirite nan faz III a pwoje LIBETE ak yon sel-ane louvri etid ekstansyon etiket. Pwoje LIBETE a gen ladan de kwa-fwontye, repetitif ak faz kritik etid klinik (LIBETE 1, LIBETE 2). Pasyan fi ak fibwom ranche akonpaye pa pedans te enskri, ak relugolix tablet konpoze te evalye pou semen 24. Pasyan ki kalifye ki te konplete syans 2 gen opotinite pou yo enskri nan yon etid ekstansyon tretman pozitif. Nan etid la ekstansyon, tout pasyan yo te resevwa relugolix-semen konpoze sou tablet, se sa ki, peryod la tretman total te 52 semen. Objektif la sete pou evalye alontem sekirite ak efikasite tretman. Apre nan fen a nan 52-semen peryod tretman total, pasyan ki kalifye yo ka chwazi yo patisipe nan yon 52 dezyem-randomized etid retre-semen, ki gen pou objaktif pou bay 2-ane sekirite ak efikasite done nan relugolix tablet konpoze ak evalye tretman an antretyen. nesesite. Nan tout etid, repons tretman te defini kom mezire pa la debaz mwen metod. Pandan denye jou yo 35 nan tretman, kantite lajan an nan pet san te redwi pa 80 ml soti nan debaz ak pa ≥ 50% soti nan debaz.

Rezilta yo te montre ke tou de LIBETE 1 ak LIBETE 2 etid rive nan pwen nan fen prensipal (p<0.0001): (1)="" in="" the="" 24th="" week="" of="" treatment,="" 73.4%="" and="" 71.2%="" of="" the="" patients="" receiving="" relugolix="" compound="" tablets="" met="" the="" response="" criteria="" and="" received="" comfort="" 18.9%="" and="" 14.7%="" of="" the="" patients="" treated="" with="" the="" drug,="" respectively;="" (2)="" on="" average,="" the="" menstrual="" blood="" loss="" of="" patients="" receiving="" relugolix="" compound="" tablets="" in="" the="" 2="" studies="" was="" 84.3%="" lower="" than="" the="" baseline="" level="" (p=""><0.0001). (3)="" at="" 24="" weeks="" of="" treatment,="" in="" 2="" studies,="" the="" bone="" density="" of="" the="" relugolix="" group="" and="" the="" placebo="" group="" were="" comparable;="" according="" to="" dual="" energy="" x-ray="" absorptiometry="" (dxa)="" assessment,="" 24="" weeks="" of="" treatment,="" the="" relugolix="" group="" and="" the="" placebo="" group="" the="" distribution="" of="" bmd="" changes="" (including="" outliers)="" is="" similar.="" (4)="" in="" 2="" studies,="" the="" total="" incidence="" of="" adverse="" events="" in="" the="" relugolix="" combination="" placebo="" group="" was="">

Etid la etiket ouve tou te rive nan endpoint prensipal la: yon ane nan tretman, vites la repons nan gwoup la relugolix te 87,7, demontre persistans nan repons yo obseve nan LIBETE 1 ak LIBETE 2. Anplis de sa, pedi san fanm yo diminye pa yon mwayen nan 89,9% soti nan debaz. DXA a ap evalye chak twa mwa, epi chanjman an nan dansite zo pandan yon ane nan tretman se ki konsistan avek LIBETE a 1 ak LIBETE 2 etid. Pami pasyan fi ki te resevwa tretman relugolix pou yon ane, evenman an ki te rapote pousantaj depase 10%, ak nan evenman ki te negatif ki depase gwoup la plasebo apre mwa 6 te selman floch.