Everest Medicines 'Nefecon® (Budesonide Delayed-Tshuaj Capsules) tau txais kev pom zoo los ntawm Singapore's Health Sciences Authority (HSA) rau kev kho mob cov neeg laus nrog thawj IgA nephropathy uas muaj kev pheej hmoo ntawm cov kab mob. Nefecon® (Budesonide Delayed-Tshuaj Capsules) tam sim no yog thawj zaug thiab tsuas yog ua rau kev kho mob rau IgA nephropathy kom tau txais kev pom zoo tag nrho los ntawm US Food and Drug Administration (FDA).
Cov txiaj ntsig kev tshawb fawb thoob ntiaj teb tau pom tias, piv nrog cov placebo, Nefecon® (Budesonide Ncua sijhawm-Tshuaj Capsules) tsis tsuas yog ua tiav qhov txo qis hauv proteinuria tab sis kuj txo qis kev pheej hmoo ntawm microscopic hematuria. Qhov tseem ceeb tshaj, nws muab cov kev kho mob tseem ceeb thiab cov txiaj ntsig kho mob tseem ceeb hauv kev kwv yees glomerular filtration rate (eGFR) (p<0.0001), reducing the rate of renal function decline by 50%. It is projected to delay the progression of the disease to dialysis or kidney transplantation by 12.8 years.
Raws li tsuas yog kev kho mob rau IgA nephropathy, Nefecon® (Budesonide Ncua sijhawm-Tshuaj Capsules) tau ua rau muaj txiaj ntsig zoo thiab cov ntaub ntawv kev nyab xeeb hauv theem 3 kev sim tshuaj NefIgArd.
Qhov ua tiav 2-cov ntaub ntawv xyoo los ntawm kev sim NefIgArd tau soj ntsuam ntxiv qhov sib txawv ntawm cov lus teb rau kev kho mob rau Nefecon® (Budesonide Ncua sijhawm-Tshuaj Capsules) ntawm cov neeg mob Asian (n=83) thiab Caucasian cov neeg mob (n=275). Cov txiaj ntsig tau qhia tias, piv nrog cov placebo, kev kho mob 9 lub hlis nrog Nefecon® (Budesonide Ncua-Release Capsules) tsis tu ncua thiab txo qis qis hauv eGFR, khaws lub raum ua haujlwm, thiab ua rau txo qis hauv proteinuria nrog rau kev pheej hmoo tsawg ntawm microscopic hematuria, hauv cov neeg Esxias thiab Caucasian.
Raws li lub ntiaj teb no tus neeg sawv cev kho mob nkaus xwb rau IgA nephropathy, Nefecon® (Budesonide Ncua -Tshuaj Capsules) yog lub plab hnyuv- phiaj xwm mucosal immune modulator. Nws txo qis lub raum tsis ua haujlwm los ntawm 50% ntawm cov pej xeem thiab nce mus txog 66% hauv cov pej xeem Suav, thiab npaj yuav ncua kev kis tus kabmob mus rau kev lim ntshav lossis hloov lub raum los ntawm 12.8 xyoo. Budesonide yog ib qho glucocorticoid uas muaj zog glucocorticoid kev ua si thiab tsis muaj zog mineralocorticoid kev ua, nrog thawj - kis metabolism ntawm 90%, sib tham txog kev nyab xeeb profile.
