Kev Kho Mob Kab Mob Tsis Txaus Ntsig Boehringer Ingelheim Nintedanib Pom Zoo Hauv EU

Lub Plaub Hlis 21, sijhawm hauv zos, Boehringer Ingelheim tshaj tawm tias Lub Chaw Saib Xyuas Kev Noj Tshuaj Hauv Tebchaws Europe (EMA) tau pom zoo nintedanib rau kev kho mob rau cov neeg mob laus uas muaj cov kab mob sclerosis-cuam tshuam rau kev mob ntsws (SSc-ILD).

Systemic sclerosis (SSc), feem ntau hu ua" scleroderma", yog qhov ua rau lub cev puas tsuaj, tsis taus, thiab muaj feem ua rau tuag taus, uas tuaj yeem ua rau ntau yam kab mob suav nrog rau lub ntsws, lub siab, lub plab zom mov, raum Cov kabmob ua rau nti fibrosis) thiab tej zaum yuav tsim kev phom sij txoj sia. Thaum lub ntsws tau mob, nws ua rau mob ntsws interstitial ntsws (ILD), hu ua SSc-ILD. Khwv yees tias txog 80% ntawm cov neeg mob SSc yuav nce mus rau ILD, uas kuj tseem yog qhov tseem ceeb rau kev tuag ntawm cov neeg mob SSc, suav txog 35% ntawm SSc-kev tuag.

Nintedanib yog lub qhov ncauj me me molecule tyrosine kinase inhibitor uas sib tw inhibits fibroblast kev loj hlob yam receptor (FGFR 1-3), vascular endothelial kev loj hlob tau receptor (VEGFR 1-3), platelet-derived kev loj hlob yam Receptors (PDGFR α thiab β) thiab lwm cov receptor tyrosine kinases thaiv cov paib uas ua lub luag haujlwm tseem ceeb hauv kev ua kom loj hlob, tsiv teb tsaws chaw thiab hloov dua siab tshiab ntawm fibroblasts, yog li inhibiting pulmonary fibrosis.

Thaum lub Cuaj Hlis 2019, nintedanib tau pom zoo los ntawm Asmeskas FDA kom ncua sijhawm lub ntsws tsis ua haujlwm hauv cov neeg laus uas muaj SSc-ILD, los ua thawj zaug thiab tam sim no tsuas yog pom zoo rau kev kho tus kab mob ntsws no. Raws li tam sim no, nintedanib tau pom zoo rau SSc-ILD cov lus qhia hauv 15 lub teb chaws, suav nrog Canada, Nyiv, thiab Brazil.

Kev pom zoo ntawm EMA tau ua tom qab Pawg Neeg Khoom Siv Kho Mob (CHMP) tau coj tus cwj pwm zoo rau kev kho nintedanib ntawm SSc-ILD rau Lub Ob Hlis 27. Kev pom zoo ntawm CHMP thiab kev pom zoo los ntawm EMA yog saib raws li kev soj ntsuam ntawm Theem III soj ntsuam kuaj mob SENSCIS. SENSCIS yog qhov kev tshawb pom loj tshaj plaws rau cov neeg mob SSc-ILD, suav nrog 576 cov neeg mob hauv 32 lub teb chaws thoob plaws ntiaj teb. Hauv txoj kev tshawb nrhiav, cov neeg mob tau muab faib rau kom tau txais nintedanib (150 mg ob zaug ib hnub) lossis placebo. Qhov kawg ntawm qhov kawg yog qhov feem pua ​​txhua xyoo ntawm poob rau hauv qhov tseem ceeb yuam kom muaj peev xwm (FVC) hauv cov neeg mob SSc-ILD. Txoj kev tshawb no kuj tau sau cov ntaub ntawv rau lwm qhov kev pom ntawm tus kabmob. Cov ntsiab lus tseem ceeb kawg yog ua kom tawv nqaij thiab tawv nqaij muaj lub neej zoo.

Cov txiaj ntsig tau pom tias tom qab 52 lub lis piam ntawm kev kho mob, siv FVC ntsuas, piv nrog cov placebo, cov neeg mob nintedanib kho pab pawg txo cov ntsws muaj nuj nqi los ntawm 44% (FVC tau kho tus nqi txo xyoo: -52. {{ 3}} ml / xyoo vs -93. 3 ml / Xyoo, qhov sib txawv: 41. 0 ml / xyoo [95% CI: 2. 9-79.0 ], p=0. 04). Txoj kev tshawb no kuj qhia tau hais tias kev nyab xeeb thiab kev zam ntawm nintedanib hauv kev kho mob ntawm SSc-ILD zoo ib yam li kev kho mob rau cov neeg mob idiopathic pulmonary fibrosis (IPF).

Qhov tseeb, SSc-ILD yog qhov qhia thib peb ntawm nintedanib. Yav dhau los, cov tshuaj tau pom zoo rau kev kho mob ntawm IPF nyob rau hauv ntau dua 75 lub teb chaws thoob ntiaj teb thiab muag hauv qab cov npe ntawm Ofev; nws tseem tau txais kev pom zoo hauv ntau lub teb chaws Nws tau muag hauv qab cov khoom lag luam npe Vargatef rau kev kho mob ntawm cov tsis mob qog nqaij hlav hauv hlwb tsawg.

Txoj kev sib luag du Nintedanib qhia yog qhov tseem ceeb heev rau Boehringer Ingelheim. Raws li kev tiv thaiv patent tas sij hawm, nws cov mob ntsws ntev (COPD) thiab mob ntsws asthma tiv thaiv Spiriva (tiotropium) kev muag khoom tau poob qis, thiab lub tuam txhab xav tau khoom sai los txhawb nws txoj kev ua pa, kev nce siab sai sai ntawm nintedanib tsis xav ua nws qhov kev xaiv zoo tshaj.

Hauv 2019, Boehringer Ingelheim ua tiav cov nyiaj tau los txhua xyoo ntawm US $ 21. 28 nphom, qeb duas 16 nyob hauv lub ntiaj teb cov tshuaj lag luam teev cov nyiaj tau los. Ntawm lawv, kev muag khoom nintedanib tau nce los ntawm 31. 6% rau 1. 6 7 billion Asmeskas las.

Nyob rau tib lub sijhawm, nintedanib' s daim ntawv lo rau cov ntsws tsis tshua muaj kab mob txuas ntxiv. Lub Kaum Hlis 10, 2019, FDA tau tso cai nintedanib kev kho mob tsim muaj kev xaiv rau kev kho mob rau cov neeg mob uas muaj mob nyuaj ua ntu zus ILD. Nrhiav rau pem hauv ntej rau nintedanib thiab ntau yam tshuaj kom tau raws li qhov xav tau tiag tiag no. (Bioon.com)