FDA pom zoo Zegalogue txhaj tshuaj los kho cov neeg mob ntshav qab zib ntshav qab zib siab heev

Ob peb hnub dhau los, Zealand Pharma tau tshaj tawm tias Tsoom Fwv Teb Chaws Asmeskas FDA tau pom zoo Zegalogue (dasiglucagon) txhaj tshuaj rau kev kho mob ntshav qab zib tsawg hauv cov menyuam yaus thiab cov neeg mob ntshav qab zib laus dua 6 xyoo thiab laus dua.

FDA tau pom zoo Zegalogue raws li kev ua tau zoo ntawm peb qhov kev xaiv ib qho, ob lub qhov muag, qhov chaw tswj xyuas, ntau lub sijhawm ntau qhov kev tshawb fawb hauv cov menyuam yaus thiab cov neeg laus uas muaj mob ntshav qab zib hom 1 txog 6 thiab 17 xyoo. Thawj qhov txiaj ntsig ntawm qhov kawg ntawm txhua qhov kev tshawb fawb yog lub sijhawm rov qab los ntawm cov ntshav qabzib nyob rau qib, uas tau txhais tias yog nce ntawm cov ntshav qabzib ntawm ≥20 mg / dL txij li hnub ntawm kev tswj hwm, thiab tsis muaj kev cuam tshuam kho ntxiv hauv 45 feeb.

Cov txiaj ntsig sim pom tau hais tias piv nrog cov placebo (lub sijhawm rov qab los ntawm 30 txog 45 feeb), cov ntshav qabzib cov ntshav rov qab los ntawm cov neeg mob tom qab Zegalogue tswj hwm tau nrawm dua, qhov nruab nrab nruab nrab rov qab siv sijhawm tsuas yog 10 feeb xwb. Qhov kev sim tau tiav mus txog thawj qhov kawg hauv ob pawg neeg laus thiab neeg mob. Hauv dua li Ntu 3 kev sim neeg laus, 99% ntawm cov neeg mob rov qab zoo li qub hauv cov ntshav nyob hauv 15 feeb. Cov kev tshwm sim tsis zoo tshaj plaws (%2%) qhia hauv kev sim muaj xws li xeev siab, ntuav, mob taub hau, raws plab, thiab qhov chaw txhaj tshuaj mob rau cov neeg laus; xeev siab, ntuav, mob taub hau, thiab qhov chaw txhaj tshuaj rau tus menyuam mob.

Kev mob ntshav qab zib tsawg nyob hauv cov neeg mob ntshav qab zib yog ib qho mob hnyav rau lub neej, feem ntau yog los ntawm cov ntshav qab zib cov ntshav qis los ntawm kev kho mob insulin, thiab yog ib qho kev txhawj xeeb tshaj plaws hauv kev kho mob ntshav qab zib. Txawm hais tias cov neeg mob tuaj yeem soj ntsuam thiab kho cov ntshav qabzib kom tswj tau cov ntshav qabzib kom zoo, nws tsis tuaj yeem tiv thaiv kom tsis txhob muaj cov ntshav qog ntshav qab zib ntau.

Sij hawm dhau los, kev pabcuam thawj zaug rau cov ntshav ntshav yog feem ntau glucagon. GlucaGen, uas Novo Nordisk tau ua lag luam rau kev kho tus mob ntshav qab zib tsawg, yog lyophilized hmoov npaj. Vim nws qis qis solubility, nws yuav tsum tau rov ua dua ib qho kev daws teeb meem ua ntej siv. Raws li cov kab kev ua ntej dej-soluble glucagon analogue, Zegalogue muaj solubility ntau dua 25mg / ml thiab tuaj yeem ntsia ua ntej hauv cwj mem thaum muaj xwm txheej ceev. Nws tuaj yeem raug txhaj ncaj qha rau hauv qab daim tawv nqaij thaum siv chaw kho mob, nws yooj yim dua thiab ruaj khov. Poj niam txiv neej.