Ozawade (pitolisant) tau pom zoo los ntawm European Union, Thiab Langyu Group tsim nws hauv Suav teb!

Lub Chaw Haujlwm Saib Xyuas Tshuaj European (EMA) tsis ntev los no tau pom zoo rau Fabkis Bioprojet tshuaj Ozawade (pitolisant) rau kev kho mob ntawm kev pw tsaug zog ntau hnub (EDS) cuam tshuam nrog obstructive pw tsaug zog apnea (OSA) hauv cov neeg laus.

Ozawade yog qhov tsim nyog rau kev kho mob cov neeg laus nrog OSA, txhim kho kev tsaug zog thiab txo EDS. Nws cov pej xeem siv tshwj xeeb yog: OSA cov neeg mob uas EDS tau txais kev kho mob tseem ceeb suav nrog kev kub siab txuas ntxiv (CPP) tab sis tsis tau kho tau zoo lossis tsis kam rau CPP.

Kev ua tau zoo thiab kev nyab xeeb ntawm Ozawade hauv kev kho EDS hauv cov neeg mob OSA tau raug soj ntsuam hauv 2 theem 3 kev tshawb fawb soj ntsuam (HAROSA I, HAROSA II). Ob txoj kev tshawb fawb no tau pom tias cov neeg mob tau txais kev kho mob Ozawade tau muaj kev txhim kho tseem ceeb hauv Epwoth Sleepiness Scale (ESS) cov qhab nia, thiab tsis muaj cov xwm txheej ntawm cov hlab plawv lossis cov kev hloov pauv tseem ceeb hauv ntshav siab / plawv dhia.

Jean-Charles Schwartz, Tus Thawj Coj Saib Xyuas Kev Tshawb Fawb thiab Co-founder ntawm Bioprojet, tau hais tias: "Kev qaug zog thiab kev pw tsaug zog ntev ntev yog cov tsos mob tshwm sim tshaj plaws ntawm cov neeg mob, uas muaj kev cuam tshuam zoo rau lawv lub neej zoo thiab kev nyab xeeb txhua hnub. Ozawade yuav muab txhua tus neeg mob nrog qhov kev daws teeb meem zoo, txawm tias lawv tau txais kev kho PPC lossis tsis kam txais kev kho PPC. Tshwj xeeb, HAROSA I thiab II cov kev tshawb fawb tau pom tias kev noj Ozawade tsis muaj kev cuam tshuam rau systolic lossis diastolic ntshav siab, thiab tsis ua rau muaj kev pheej hmoo siab ntshav siab. Qhov tseeb. Ozawade' hom kev ua yog txawv ntawm psychostimulants, uas ua rau nws muaj kev nyab xeeb dua, uas yog ib qho tseem ceeb heev rau cov pej xeem uas feem ntau nrog cov kab mob metabolic thiab cov hlab plawv."

Wakix-pitolisant chemical qauv

Cov khoom siv tshuaj nquag ntawm Ozawade yog pitolisant, uas yog xaiv cov tshuaj histamine 3 (H3) receptor antagonist / inverse agonist, uas ua rau muaj kev ua haujlwm ntawm histamine, cov neurotransmitter uas txhawb nqa lub hlwb los ntawm kev txhim kho cov haujlwm ntawm histaminergic neurons. Synthesis thiab tso tawm, txhim kho tus neeg mob' s sobriety thiab alertness.

pitolisant tau pom zoo rau kev lag luam hauv European Union thiab Tebchaws Meskas thaum Lub Peb Hlis 2016 thiab Lub Yim Hli 2019. Nws yog muag raws li lub npe lag luam Wakix® rau kev kho mob ntawm narcolepsy nrog lossis tsis muaj cataplexy. Nws yuav raug pom zoo los ntawm Tebchaws Meskas hauv 2020. FDA tau txheeb xyuas tias nws yog ib qho tshuaj kho mob rau cov neeg mob narcolepsy.

Pitolisant tau tsim los ntawm Bioprojet. Langhua Pharmaceutical, lub chaw muag khoom ntawm RareStone Group, tau kos npe rau daim ntawv cog lus nrog Bioprojet thaum kawg ntawm 2020 kom tau txais txoj cai kev lag luam hauv Suav lag luam.

Raws li tsab ntawv tshaj tawm los ntawm Langyu Group, thaum lub Tsib Hlis 7 xyoo no, Wakix® tau tshaj tawm thawj cov tshuaj hauv tsev ntawm Hainan Boao Yiling Lub Chaw Txhim Kho Lub Neej Zoo. Ua tsaug rau txoj cai kev faib nyiaj ntawm Boao Lecheng Pioneer Zone, qhov kev ua txhaum ntawm cov tshuaj no rau kev kho mob narcolepsy tau ua tiav thawj daim ntawv thov kev kho mob hauv kuv lub tebchaws, nqa cov phiaj xwm kho mob tshiab tshaj plaws synchronized nrog lub ntiaj teb' qib siab rau cov neeg mob. nrog narcolepsy hauv Suav teb.

Thaum Lub Xya Hli Ntuj xyoo no, Langyu Group tau xa Daim Ntawv Thov Kev Lag Luam Tshiab (NDA) rau Wakix® (pitolisant) rau National Medical Products Administration (NMPA) rau kev kho mob ntawm narcolepsy nrog lossis tsis muaj cataplexy. Wakix® (Tilorisen) xav tias yuav dhau los ua thawj cov tshuaj kho mob pom zoo rau kev kho mob narcolepsy hauv Suav teb.

Narcolepsy yog ib qho ntawm cov kab mob tsis tshua pom muaj thoob ntiaj teb. Nws yog ib qho kab mob loj heev uas tshwm sim los ntawm kev tsaug zog ntev ntev (EDS), nrog lossis tsis muaj cataplexy. Tam sim no, muaj ntau dua 700,000 tus neeg mob narcolepsy hauv kuv lub tebchaws, thiab tsis muaj tshuaj tau pom zoo rau kev kho mob narcolepsy. Cov kws kho mob muaj kev xaiv tsawg heev hauv kev kho mob narcolepsy. Ntau tus neeg mob tau plagued los ntawm tus kab mob. Muaj kev xav tau kev kho mob loj heev rau kev kho tus kab mob.