Roche Ocrevus Kev Xaj Qo Tshiab Kev Pom Zoo Pom Zoo Los Ntawm EU

Lub Tsib Hlis 28, Roche tshaj tawm tias Lub Chaw Haujlwm Saib Xyuas Kev Noj Tshuaj hauv Tebchaws Europe (EMA) tau pom zoo Ocrevus (ocrelizumab) txoj kev noj tshuaj tshiab, luv dua-sijhawm siv 2-teev kev noj qab haus huv, tswj xyuas ob zaug hauv ib xyoos rau kev rov mob lossis thawj kev kho mob ntawm ntau yam sclerosis (MS). Qhov kev pom zoo no yog raws li kev soj ntsuam zoo ntawm EMA Committee rau Tib neeg cov Khoom Kho Mob (CHMP).

Qhov kev pom zoo tau txiav txim siab los ntawm cov ntaub ntawv los ntawm kev siv ib cov ntaub ntawv tshawb pom los ntawm randomized, ob lub qhov muag dig. Txoj kev tshawb no qhia tau tias hauv cov neeg mob rov mob rov qab ntau tus mob sclerosis (RRMS) (289 tus neeg mob tau txais 2-teev infusion thiab 291 cov neeg mob tau txais qhov 3.5-teev infusion), 2-teev infusion thiab 3.5-teev infusion muaj kev cuam tshuam nrog infusion-cuam tshuam. teb (IRR) zaus thiab qhov mob hnyav yog qhov sib piv. Hauv txoj kev tshawb nrhiav, thawj koob tshuaj yog raws li kev pom zoo koob tshuaj pom zoo (ob 300 mg IV [IV] infusions, sib cais los ntawm 2 lub lis piam), thiab koob thib ob lossis tom qab (600 mg IV Txoj kev lis ntshav) tau muab rau txo qis 2- teev sijhawm.

Thawj qhov kawg ntawm txoj kev tshawb no yog qhov feem ntawm cov neeg mob uas muaj IRR tom qab thawj zaug kev pheej hmoo (qhov nquag thiab qhov kev ntsuas qhov hnyav thaum lub sijhawm thiab 24 teev tom qab infusion). Cov txiaj ntsig tau pom tias qhov xwm txheej ntawm IRR yog qhov sib piv ntawm 2-teev infusion pawg (24.6%) thiab 3.5-teev infusion pawg (23.1%). Ob pawg ntawm IRR feem ntau yog mob sib khuav lossis mob me, thiab ntau tshaj li 98% tau daws yam tsis muaj teeb meem. Tsis muaj kev phom sij rau lub neej, mob hnyav thiab tuag taus IRR tshwm sim. Tsis muaj tus neeg mob txuas mus ntxiv rau qhov kev tshawb fawb vim IRR thiab tsis muaj lub cim qhia txog kev nyab xeeb tshiab.

Tsoom Fwv Teb Chaws Asmeskas FDA tseem tau lees txais Ocrevus 2 teev kev sib xyaw ua kua tshuaj ntxiv cov ntawv thov cov khoom siv roj ntsha (sBLA), yuav tsum txiav txim siab txog lub Kaum Ob Hlis 14 xyoo no.

Ocrevus yog tib neeg cov monoclonal antibody tiv thaiv CD20-zoo B hlwb, uas yog hom kev tiv thaiv kab mob ntawm lub cev thiab tau xav tias raug mob los ntawm myelin sheaths (neural cell cais thiab txhawb nqa) thiab axons (cov paj hlwb) Qhov tseem ceeb tshaj. No lub xovtooj ntawm qhov puas tsuaj tuaj yeem ua rau muaj mob xiam oob qhab hauv MS cov neeg mob. Raws li kev tshawb fawb pom, Ocrevus khi rau qee yam ntawm CD20 cell xovtooj rau cheeb tsam cov roj ntsha uas qhia los ntawm B hlwb, tab sis tsis yog qia hlwb lossis ntshav hlwb, qhia tias tseem ceeb ntawm cov kab mob hauv lub cev muaj peev xwm yuav tshwj tau.

Ocrevus tau pom zoo rau kev lag luam hauv lub Peb Hlis 2017. Vim tias qhov tshuaj kho tau zoo tsuas yog ob zaug hauv ib xyoos, ib zaug nws ua lag luam, nws tau txais sai sai los ntawm cov neeg mob. Tam sim no, Ocrevus tau pom zoo hauv 90 lub teb chaws thoob ntiaj teb. Ocrevus 'qhov kev paub tiag tiag tau hloov sai sai, nrog ntau dua 160,000 cov neeg mob tau txais kev kho mob thoob ntiaj teb. Cov tshuaj tau muab tshuaj ob zaug hauv ib xyoos thiab yog thawj zaug thiab tsuas yog pom zoo rau kev kho mob RMS (suav nrog RRMS, nquag lossis mob siab ntxiv MS, thiab qhov chaw kho mob cais nyob hauv Tebchaws Meskas) thiab thawj hom kev siv tshuaj MS.

Raws li daim ntawv qhia ua haujlwm tau tso tawm los ntawm Roche, Ocrevus' kev muag khoom thoob ntiaj teb hauv 2019 ncav cuag CHF 3.708 billion, nce 57% dua xyoo dhau los. Hauv thawj peb lub hlis xyoo no, Ocrevus' kev muag khoom tau nce mus txog 1.112 billion Swiss francs, nce ntxiv ntawm 38% nyob rau tib lub sijhawm ntawm lub xyoo dhau los.