Asmeskas FDA tso cai Wynzora (calccipotriol / betamethasone dipropionate) cream!

MC2 Kev Kho Mob yog lub tuam txhab ua lag luam tshuaj tsom rau kev tsim cov qauv tshiab rau kev kho mob hauv zos ntawm kev mob o. Tsis ntev los no, lub tuam txhab tshaj tawm tias Asmeskas Chaw Tswj Xyuas Khoom Noj thiab Tshuaj (FDA) tau pom zoo Wynzora cream (calcipotriol thiab betamethasone dipropionate, w / w, 0.005% / 0.064%) raws li kev kho mob ib zaug rau ib hnub, Rau kev kho mob ntawm cov quav hniav mob psoriasis hauv cov laus ≥18 xyoos. Tsis ntev los no, lub tuam txhab kuj tau xa daim ntawv thov kev tso cai muag lag luam (MAA) rau Wynzora cream los kho tus mob plaque psoriasis neeg laus hauv EU.

Wynzora cream yog hom tshuaj-ua ke sib xyaw ntawm cov khoom qab zib-raws li calcipotriol thiab betamethasone dipropionate rau kev kho mob ntawm cov quav hniav psoriasis. Wynzora qab zib yog raws li PAD thev naus laus zis, uas tshwj xeeb ua rau calcipotriene thiab betamethasone dipropionate ruaj khov hauv cov aqueous formulations yooj yim. Hauv Ntu III kev sim los ntawm ntau lub chaw kho mob hauv Tebchaws Meskas thiab European Union, Wynzora cream tau qhia tshwj xeeb sib xyaw ua ke hauv kev kho mob kom tau txais txiaj ntsig, kev nyab xeeb zoo thiab yooj yim. Cov yam ntxwv ntawm Wynzora lee cia siab tias yuav txo qis kev cuam tshuam kev kho mob thaum kev kho mob hauv zos ntawm cov quav hniav psoriasis hauv qhov chaw ib puag ncig thiab txhim kho kev mob siab rau cov neeg mob tag nrho.

Hauv kev hais txog kev noj tshuaj, Wynzora tau siv rau thaj chaw muaj cuam tshuam ib hnub ib zaug rau 8 lub lim tiam thiab tsis pub dhau 100 grams toj ib lis piam. Thaum cov quav hniav psoriasis tau tswj hwm, cov neeg mob yuav tsum tso tseg kev kho mob. Tshwj tsis yog kws kho mob muab lwm yam lus qhia. Wynzora cream tsuas yog siv rau ntawm daim tawv nqaij (tshuaj pleev).

Kev pom zoo ntawm FDA yog raws li kev soj ntsuam Phase III hauv tebchaws Meskas. Qhov kev sim siab piv rau Wynzora lee nrog cov tshuaj zoo tswj Taclonex tshuaj pleev ib ce (calcipotriol thiab betamethasone dipropionate, w / w, 0.005% / 0.064%). Tag nrho ntawm 794 cov neeg mob hauv qhov kev sim no tau xaiv ntau. Thawj qhov kev ua tau zoo kawg yog qhov sib piv ntawm cov neeg mob uas tau txais kev kho mob tau zoo los ntawm kws kho mob qhov kev ntsuam xyuas tag nrho (PGA) ntawm 8 lub lim tiam ntawm kev kho, txhais tau tias yog kev txhim kho hauv PGA los ntawm qhov pib los ntawm tsawg kawg 2 qib mus rau "ua kom tiav kev pom meej" lossis" Yuav luag txhua qhov kom meej meej."

Cov ntaub ntawv pom tau hais tias piv nrog Taclonex pawg tswj hwm, qhov kev vam meej ntawm PGA hauv pawg kho mob Wynzora tau nce 14.6% (95% CI: 7.6%, 21.6%; p< 0.0001).="" ib="" qho="" ntxiv,="" los="" ntawm="" kev="" soj="" ntsuam="" hauv="" lub="" hauv="" paus="" mus="" rau="" 4="" lub="" lim="" tiam="" ntawm="" kev="" kho="" mob,="" qhov="" kev="" txo="" qis="" ntawm="" qhov="" mob="" pruritus="" txhais="" los="" ntawm="" 11-qhov="" siab="" tshaj="" qhov="" ua="" tau="" zoo="" siab="" teev="" (nrs)="" tau="" nce="" los="" ntawm="" tsawg="" kawg="" 4="" cov="" ntsiab="" lus,="" qhov="" feem="" ntawm="" cov="" neeg="" mob="" uas="" tau="" txo="" tus="" mob="" pruritus="" hauv="" pawg="" wynzora="" tau="" nce="" siab="" tshaj="" qhov="" ntawd="" hauv="" pawg="" tsis="" muaj="" yeeb="" tshuaj="" (60.3%="" vs="">

Tus kws tshawb fawb txog kev tshawb fawb, Dr. Linda Stein Gold, Tus Neeg Saib Xyuas Kev Tshawb Fawb ntawm Dermatology ntawm Henry Ford Health System hauv Detroit, Michigan tau hais tias:" Wynzora cream yog hom tshiab los kho mob plaque psoriasis uas muab ib yam khoom nkaus xwb Kev sib xyaw ua ke ntawm kev ua haujlwm siab, kev nyab xeeb thiab kev kho kom yooj yim."

MC2 Tus Thawj Coj Jesper J. Lange tau hais tias: “Kev pom zoo ntawm FDA yog lub cim tseem ceeb rau cov neeg mob plaque psoriasis. Peb lub tshuab PAD tso cai rau peb los tsim Wynzora W qab zib yam tsis muaj kev sib cav sib ceg. Nws txhawb nqa Wynzora® Cov ntaub ntawv pov thawj kev nyab xeeb thiab kev nyab xeeb ntawm cov tshuaj nplaum, thiab cov qauv tsim nyog ntawm cov ntaub ntawv no rau hauv kev cuam tshuam rau tus neeg mob, kom tus neeg mob tuaj yeem txuas mus ntxiv kev kho mob nyob hauv ob peb feeb tom qab kev kho mob thaum sawv ntxov. Nws ua rau tus neeg mob rov qab tswj hwm txoj kev kho mob thiab Lub neej txhua hnub."