Eli Lilly Thiab Daiichi Sankyo Tau Txais Daim Ntawv Pom Zoo Ua Lag Luam Los Muag 5-HT1F Agonist Reyvow hauv Nyij Pooj

Eli Lilly thiab Daiichi Sankyo tau tshaj tawm tsis ntev los no tias ob tog tau pom zoo txog kev lag luam ntawm 5-HT1F receptor agonist Reyvow (lasmiditan) hauv Nyij Pooj. Eli Lilly tau xa nws hauv Nyij Pooj. Reyvow' Daim Ntawv Thov Tshuaj Tshiab (NDA) rau kev kho mob hnyav ntawm mob taub hau.

Yav dhau los, ob tog tau kos npe pom zoo rau kev muag Eli Lilly's migraine drug Emgality (galcanezumab) hauv Nyij Pooj, uas yog tib neeg los tiv thaiv calcitonin noob cuam tshuam nrog peptide (CGRP) monoclonal antibody tsim los ntawm recombinant DNA thev naus laus zis. Ua rau kev tiv thaiv kev kho mob migraine.

Zoo ib yam li Emgality, raws li cov lus cog tseg ntawm qhov kev pom zoo zaum kawg no, Eli Lilly yuav tuav daim ntawv tso cai muag khoom ntawm Reyvow hauv Nyij Pooj. Tom qab pom zoo, Daiichi Sankyo yuav muaj lub luag haujlwm rau kev faib khoom thiab muag khoom. Ob lub tuam txhab yuav muab cov kws kho mob paub txog cov tshuaj.

Raws li nws txoj haujlwm thiab network hauv thaj tsam ntawm cov kab mob hauv nruab nrab lub paj hlwb thiab tswj kev mob, Daiichi Sankyo muaj lub hauv paus kev lag luam ruaj khov hauv Nyij Pooj. Los ntawm kev lag luam koom tes nrog Daiichi Nuclear Sankyo, Eli Lilly cov neeg nyob hauv Nyij Pooj yuav txhawb nws txoj hauv kev muab cov ntaub ntawv tsim nyog rau cov kws kho mob los ntawm Emgality thiab Reyvow tom qab tau txais kev pom zoo ua lag luam.

Daiichi Sankyo yuav ua haujlwm txhawm rau txhim kho lub neej zoo ntawm cov neeg mob migraine ntau dua, thiab muab cov neeg mob nrog kev txhawb nqa kev saib xyuas tas mus li los ntawm Emgality, tshuaj rau tiv thaiv kev mob taub hau, thiab Reyvow, tshuaj rau kev kho mob taub hau. Eli Lilly thiab Daiichi Sankyo yuav txhawb kev kho mob migraine hauv Nyij Pooj los ntawm kev lag luam ntawm ob hom tshuaj.

lasmiditan tshuaj qauv

Mob taub hau yog ib yam kab mob neurovascular ntev uas tshwm sim los ntawm mob taub hau hnyav, feem ntau yog ib sab. Tam sim no, tsis muaj tshuaj uas tuaj yeem kho mob taub hau. Lub Koom Haum Saib Xyuas Kev Noj Qab Haus Huv Ntiaj Teb (WHO) tau teev npe mob taub hau yog ib ntawm 10 tus kab mob uas tsis taus tshaj plaws.

Reyvow yog cov tshuaj sau tshuaj hais qhia pom zoo los ntawm Asmeskas FDA thaum Lub Kaum Hli 2019 rau kev kho mob hnyav ntawm mob taub hau nrog lossis tsis muaj aura hauv cov neeg laus. Reyvow sawv cev rau thawj chav kawm tshiab ntawm cov tshuaj kho mob taub hau uas tau pom zoo los ntawm FDA hauv ntau dua 20 xyoo. Cov tshuaj no yog thawj 5-HT1F receptor agonist pom zoo los ntawm FDA, uas tuaj yeem ua rau lub hauv nruab nrab thiab lub paj hlwb nyob rau tib lub sijhawm. Nws cov txheej txheem ntawm kev ua yog txawv ntawm lwm cov tshuaj mob taub hau mob tam sim no ntawm kev ua lag luam. Nws yuav tsum raug sau tseg tias Reyvow tsis haum rau kev tiv thaiv kev kho mob migraine. Cov lus qhia tshwj xeeb ntawm cov tshuaj yog 50mg, 100mg, thiab 200mg, uas tuaj yeem xaiv tau yooj yim raws li xav tau.

Hauv kev tshawb fawb soj ntsuam, Reyvow tshem tawm sai thiab mob taub hau tag nrho thiab nws cov tsos mob tsis zoo tshaj plaws (xeev siab, lub teeb pom kev lossis hnov ​​suab nrov) hauv tsuas yog 2 teev nrog rau ib qho tshuaj nkaus xwb. Cov lus qhia tshiab tshaj tawm los ntawm US FDA thiab American Headache Association tau tsa cov txheej txheem kho mob. Nws tau pom zoo tias qhov ua tau zoo ntawm kev siv tshuaj tiv thaiv kab mob migraine xav tau los ua pov thawj tshem tawm qhov mob thiab tshem tawm ntawm cov tsos mob tsis zoo tshaj plaws, tsis yog kho qhov mob. Reyvow yog thawj qhov tshuaj pom zoo los ntawm FDA rau kev kho mob hnyav mob taub hau uas ua tau raws li tus txheej txheem tshiab no.

Cov khoom siv tshuaj muaj zog ntawm Reyvow yog lasmiditan, uas yog qhov ncauj, hauv nruab nrab lub paj hlwb lub zog nkag mus tau, xaiv tau, serotonin 1F (5-HT1F) agonist, tus yam ntxwv thiab khoos phis tawj sib txawv los ntawm kev pom zoo tam sim no tshuaj, thiab tsis muaj vasoconstrictor kev ua. Nws tsim nyog hais tias lasmiditan yog thawj zaug thiab tsuas yog cov tshuaj pom zoo rau kev kho mob hnyav ntawm cov neeg laus mob taub hau hauv&"ditan &"; qeb tshuaj. Qhov kev pom zoo no sawv cev thawj qhov kev hloov pauv tseem ceeb hauv kev kho mob migraine mob hnyav hauv ntau dua 20 xyoo.