Kerendia (finerenone) tab tom yuav raug pom zoo hauv EU, thiab tau raug tshuaj xyuas hauv Suav teb!

Bayer tsis ntev los no tau tshaj tawm tias European Tshuaj Lub Chaw Haujlwm (EMA) Pawg Neeg Saib Xyuas Kev Kho Mob rau Tib Neeg Siv (CHMP) tau tshaj tawm kev tshuaj xyuas zoo qhia pom zoo rau Kerendia (finerenone, 10mg lossis 20mg) rau kev kho mob ntawm cov neeg laus thiab hom 2 mob ntshav qab zib (T2D) Muaj feem cuam tshuam rau mob raum (CKD, theem 3 thiab 4 nrog proteinuria). Txawm hais tias tam sim no muaj kev xaiv kho mob, ntau tus neeg mob T2D ntsig txog CKD yuav ua rau lub raum tsis ua haujlwm lossis tuag ntxov. Cov neeg mob tam sim no xav tau kev kho mob uas tuaj yeem ncua kev loj hlob ntawm cov kab mob raum thiab txo qhov kev pheej hmoo ntawm cov kab mob plawv.

Kerendia (finerenone) yog ib qho pioneering, uas tsis yog-steroidal, xaiv mineralocorticoid receptor antagonist (MRA), uas tuaj yeem txo cov teebmeem ntawm kev ua kom ntau dhau ntawm mineralocorticoid receptor (MR). Kev ua kom ntau dhau ntawm MR tuaj yeem ua rau mob thiab fibrosis, uas yog cov tsav tsheb tseem ceeb ntawm CKD kev loj hlob thiab lub plawv puas.

Thaum Lub Xya Hli 2021, Kerendia tau pom zoo los ntawm US FDA los ntawm cov txheej txheem tshuaj xyuas tseem ceeb rau kev kho cov neeg laus cov neeg mob raum mob ntev (CKD) ua ke nrog hom 2 mob ntshav qab zib mellitus (T2D), txo qis qis hauv kwv yees glomerular filtration rate (eGFR) , Kev pheej hmoo ntawm cov kab mob hauv lub raum kawg (ESKD), kev tuag ntawm cov hlab plawv, tsis ua rau mob myocardial infarction, thiab mus pw hauv tsev kho mob rau lub plawv tsis ua haujlwm. Tam sim no, cov tshuaj tseem tab tom saib xyuas kev tswj hwm los ntawm European Union, Tuam Tshoj thiab qee lub tebchaws.

It is worth mentioning that Kerendia is the first non-steroidal selective MRA to show positive renal and cardiovascular outcomes in patients with CKD and T2D. Despite guidelines-guided treatments, many patients with CKD and T2D will still develop loss of renal function and have a high risk of cardiovascular events. The mechanism of action of Kerendia is different from existing therapies. By blocking the excessive activation of MR, the drug can directly target inflammation and fibrosis to delay the progression of the disease.

Txoj kev tshawb fawb FIDELIO-DKD tau ua rau cov neeg mob CKD thiab T2D los ntsuas qhov ua tau zoo thiab kev nyab xeeb ntawm finerenone thiab placebo. Ob pab pawg tau txais kev saib xyuas tus qauv, suav nrog kev kho mob hypoglycemic thiab qhov siab tshaj plaws ntawm cov tshuaj renin-angiotensin system (RAS) thaiv kev kho, xws li angiotensin-hloov enzyme (ACE) inhibitors lossis angiotensin II receptors Blocker (ARB).

Tsis tas li ntawd, nrog kev soj ntsuam nruab nrab ntawm 2.6 xyoo, piv nrog cov placebo, finerenone kuj tseem txo cov kev pheej hmoo ntawm cov ntsiab lus tseem ceeb thib ob: txo qhov kev pheej hmoo ntawm cov hlab plawv tuag, tsis tuag myocardial infarction, tsis mob stroke lossis lub plawv tsis ua haujlwm hauv tsev kho mob. nyob 14% (tus txheeb ze kev pheej hmoo txo, HR=0.86 [95% CI: 0.75-0.99; p=0.0339]).

Nyob rau hauv txoj kev tshawb no, finerenone tau zoo zam, raws li kev nyab xeeb pom nyob rau hauv cov kev tshawb fawb yav dhau los. Tag nrho cov xwm txheej tsis zoo thiab cov xwm txheej tsis zoo tshwm sim los ntawm kev kho mob zoo ib yam ntawm ob pawg. Cov xwm txheej tsis zoo feem ntau yog me me lossis nruab nrab. Piv nrog rau cov placebo pab pawg, qhov zaus ntawm cov xwm txheej tsis zoo yog qis dua hauv pawg finerenone (31.9% vs 34.3%) thiab qhov tshwm sim ntawm hyperkalemia-txog cov xwm txheej tsis zoo yog siab dua (18.3% vs 9%), thiab ob pawg tau mob hnyav. ntsig txog hyperkalemia Qhov tshwm sim ntawm cov xwm txheej tsis zoo yog tsawg (1.6% vs 0.4%), thiab tsis muaj hyperkalemia-txog kev tuag ntawm ob pawg. Qhov feem pua ​​​​ntawm cov neeg mob uas tsis tau txais kev kho mob ntxiv vim hyperkalemia hauv pawg finerenone yog 2.0%, piv nrog 0.9% hauv pawg placebo.