Qhov thib ob-tiam qhov ncauj thrombopoietin receptor agonist Doptelet (avatrombopag) yuav pom zoo sai sai hauv EU!

Lub tuam txhab lag luam tshuaj lag luam Swedish Orphan Biphanitrum AB (SOBI) tau tshaj tawm tam sim no tias Pawg Neeg Saib Xyuas Kev Noj Tshuaj hauv Tebchaws Europe (EMA) rau Cov Khoom Siv Tshuaj rau Cov Neeg Siv (CHMP) tau tshaj tawm cov lus pom zoo, pom zoo pom zoo kom nthuav dav daim ntawv thov ntawm Doptelet (avatrombopag ) rau kev kho mob Cov neeg laus uas mob thawj zaug uas muaj lub cev tsis muaj zog tiv thaiv thrombocytopenia (ITP) uas tsis tau teb rau lwm yam kev kho mob (xws li corticosteroids, immunoglobulins). Tam sim no, CHMP cov lus pom yuav muab xa mus rau European Commission (EC) rau kev tshuaj xyuas, uas feem ntau ua qhov kev txiav txim siab zaum kawg li ntawm 2 hlis.

Kev txhaj tshuaj tiv thaiv kab mob rau lub cev (ITP) yog ib tus kabmob autoimmune uas tsis muaj cov ntshav txhaws qis, ua rau muaj kev pheej hmoo ntawm nqaij doog thiab los ntshav. Nws kwv yees hais tias 100 tawm ntawm txhua lab tus tib neeg muaj ITP, thiab thaum cov tsos mob mus ntev dua 12 lub hlis, tus kab mob no suav tias yog mob ntev. Qhov tshwm sim ntawm thawj ITP hauv cov neeg laus yog 3.3 ntawm 100,000 tus neeg hauv ib xyoos. Tam sim no, tsis muaj tshuaj rau ITP. Cov neeg mob no feem ntau huam tuaj tom qab tau txais ntau yam kev kho mob thiab tseem xav tau tshuaj los txhawm rau txo cov kev pheej hmoo loj los ntshav hauv chaw kho mob.

Doptelet' s cov tshuaj ua kom zoo avatrombopag yog lub cim thib ob, ib zaug-lub qhov ncauj thrombopoietin receptor agonist (TPO-RA) uas tuaj yeem qog cov teebmeem ntawm TPO, uas yog tus kws tswj lub zog platelet ntau lawm.

Hauv Tebchaws Meskas, Doptelet tau pom zoo los ntawm FDA rau lub Tsib Hlis 2018 rau kev kho mob ntawm thrombocytopenia hauv cov neeg mob laus lub siab mob ntsws siab (CLD) uas npaj yuav phais mob. Thaum Lub Rau Hli Ntuj 2019, FDA tau pom zoo nthuav dav ntawm txoj kev thov ntawm Doptelet rau kev kho mob ntawm thrombocytopenia hauv cov neeg mob cov neeg laus uas muaj kev tiv thaiv kab mob ntsws tsis paub qab hau (ITP) uas tsis tau teb rau kev kho mob yav dhau los. Hauv Tebchaws Europe, Doptelet tau pom zoo rau lub Rau Hli 2019 rau kev kho mob ntawm thrombocytopenia hauv cov neeg mob loj uas muaj CLD uas tab tom npaj yuav phais mob yam tsis muaj mob dabtsi.

SOBI Tus Thawj Saib Xyuas Kev Kho Mob thiab Lub Taub Hau ntawm Kev Tshawb Fawb thiab Kev Loj Hlob Ravi Rao tau hais tias:" Cov xov xwm no yog cov kauj ruam tseem ceeb hauv kev muab kev kho mob rau cov neeg mob ITP European. Hnub no' s lub tswv yim zoo los ntawm CHMP yog lub sijhawm tseem ceeb rau ITP cov neeg mob thoob plaws Europe. Yog tias koj tau txais Nrog kev pom zoo ntawm European Commission, Doptelet yuav muab cov neeg mob thiab cov kws paub txog kev noj qab haus huv nrog txoj kev kho lub qhov ncauj tshiab yam tsis muaj kev txwv rau cov zaub mov."