Tebchaws Asmeskas FDA tau pom zoo Nuzyra (omadacycline) rau kev tswj hwm qhov ncauj nkaus xwb, thiab nkag mus rau qhov tseem ceeb tshuaj xyuas hauv Suav teb!

Zai Lab' tus koom tes Paratek Pharmaceuticals tsis ntev los no tshaj tawm tias Asmeskas Khoom Noj thiab Tshuaj Yeeb Tshuaj (FDA) tau pom zoo daim ntawv thov tshuaj ntxiv (sNDA) rau Nuzyra (omadacycline): Nuzyra tsuas yog siv los ntawm ncauj (qhov ncauj nkaus xwb) kev noj tshuaj) rau kev kho mob ntawm cov neeg laus uas muaj tus kab mob ntsws tau txais los ntawm zej zog (CABP). Yav dhau los, Nuzyra' kev tswj hwm kev tswj hwm rau CABP yog kev tswj hwm qhov ncauj.

Tsis ntev los no, FDA kuj tau pom zoo Nuzyra' qhov kev siv tshuaj qhov ncauj rau kev kho mob ntawm cov kab mob tawv nqaij tawv nqaij thiab mob nqaij (ABSSSI) hauv cov neeg laus. Yav dhau los, Nuzyra' kev noj tshuaj rau kev kho mob ntawm ABSSI kuj yog kev tswj hwm qhov ncauj.

Nuzyra tau pom zoo los ntawm FDA thaum Lub Kaum Hli 2018. Cov tshuaj no yog cov tshuaj tua kab mob tetracycline niaj hnub no uas tau txhaj tshuaj los yog txhaj tshuaj ib hnub ib zaug rau kev kho mob CABP thiab ABSSSI. Qhov kev pom zoo tshiab qhov ncauj nkaus xwb yuav ua rau cov kws kho mob kho cov neeg mob hauv tsev kho mob lossis chaw kho mob thawj, txo lossis tshem tawm cov kev pheej hmoo thiab nqi thaum mus pw hauv tsev kho mob thiab mus pw hauv tsev kho mob.

Omadacycline yog hom tshuaj tshiab ntawm 9-aminomethylcycline tshuaj. Nws yog cov khoom siv hluavtaws uas tau txais los ntawm kev hloov kho cov tshuaj lom neeg los ntawm tetracycline tshuaj tua kab mobminocycline tshuaj. Nws tau tsim tshwj xeeb kom kov yeej tetracycline tsis kam thiab tsom mus rau ntau yam kab mob. Cov tshuaj tua kab mob muaj zog, suav nrog cov kab mob gram-positive, kab mob gram-tsis zoo, cov kab mob anaerobic, cov kab mob atypical thiab lwm yam kab mob tiv taus.

Thaum lub Plaub Hlis 2017, Zai Lab tau koom tes nrog Paratek thiab tau txais txoj cai tshwj xeeb los tsim thiab ua lag luam omadacycline hauv Suav lag luam. Thaum Lub Ob Hlis 2020, National Medical Products Administration (NMPA) lees txais daim ntawv thov kev lag luam tshuaj tshiab rau omadacycline rau kev kho mob ntawm CABP thiab ABSSSI. Thaum pib ntawm lub Tsib Hlis 2020, NMPA tau tso cai tshuaj xyuas qhov tsim nyog rau omadacycline daim ntawv thov kev lag luam tshuaj tshiab.

Nws tsim nyog hais txog tias thaum Lub Peb Hlis 2020, Hisun Pharmaceuticals tau tshaj tawm hais tias nws pom zoo rau nws tus tub xeeb ntxwv lub tuam txhab Huizheng (Shanghai) Pharmaceutical Technology Co., Ltd. thiab Zai Lab kos npe rau" quot; rau kev txhaj tshuaj omadacycline thiab ntsiav tshuaj hauv qhov ncauj. Raws li cov lus cog tseg, Zai Lab xaiv Hui' tshwj xeeb tshaj tawm kev pabcuam rau kev txhaj tshuaj omadacycline thiab cov ntsiav tshuaj ntawm qhov ncauj hauv thaj chaw pabcuam (Suav, tabsis tsis suav nrog Hong Kong Tshwj Xeeb Cheeb Tsam, Macau Tshwj Xeeb Cheeb Tsam thiab Taiwan).

Adam Woodrow, Thawj Tswj Hwm thiab Tus Thawj Saib Xyuas Kev Lag Luam ntawm Paratek, tau hais tias:" Kev pom zoo ntawm Nuzyra' kev noj tshuaj qhov ncauj tag nrho rau kev mob ntsws yog qhia txog lub sijhawm tseem ceeb rau cov kws kho mob los kho cov neeg mob hauv tsev kho mob lossis chaw kho mob thawj zaug. . Kev kho nyob rau hauv txoj kev no, Muaj peev xwm txo lossis tshem tawm hauv tsev kho mob thiab cuam tshuam txog kev pheej hmoo thiab nqi thaum mus pw hauv tsev kho mob. Peb yuav nthuav peb txoj kev tshaj tawm kom suav nrog qhov kev noj tshuaj tshiab no, thiab peb zoo siab tshwj xeeb los nqa cov tshuaj tua kab mob qhov ncauj tshiab, nyab xeeb thiab muaj txiaj ntsig rau cov kws kho mob thawj zaug kom txais tos lub caij mob ntsws yuav los tom ntej."

Christian Sandrock, tus xibfwb ntawm tshuaj kho mob ntsws thiab tus thawj coj saib xyuas mob hnyav ntawm UC Davis Kev Noj Qab Haus Huv, tau hais tias: "Raws li kev tiv thaiv kab mob tseem ceeb thiab teeb meem kev nyab xeeb tseem ceeb ntawm cov tshuaj tua kab mob qub qub, kev kho mob hnyav hauv zej zog suav nrog kev mob ntsws tau kis ntau zuj zus. nyuaj. Raws li qhov tsis muaj peev txheej thiab kev hloov pauv tshiab hauv cov tshuaj tiv thaiv kab mob hauv 20 xyoo dhau los, cov kws kho mob hauv zej zog xav tau cov kev xaiv tshiab uas muaj txiaj ntsig thiab nyab xeeb. Ntawm cov neeg mob uas mob ntsws, muaj Nuzyra' lub qhov ncauj noj tshuaj kom pab daws qhov teeb meem. Muaj qhov sib txawv ntawm qhov xav tau kom muaj txiaj ntsig zoo, nyab xeeb, thiab tau txais tshuaj tiv thaiv kab mob hauv qhov ncauj zoo hauv thawj qhov chaw saib xyuas mob."