EU CHMP pom zoo kev pom zoo ntawm Pfizer's 2 JAK inhibitors Cibinqo (abxitinib) thiab Xeljanz (tofacitinib)!

Pfizer tsis ntev los no tau tshaj tawm tias European Tshuaj Lub Chaw Haujlwm (EMA) Pawg Neeg Saib Xyuas Tshuaj Kho Mob rau Tib Neeg Siv (CHMP) tau tshaj tawm qhov kev tshuaj xyuas zoo qhia txog kev pom zoo ntawm Cibinqo (abrocitinib, 100mg, 200mg): cov tshuaj yog ib qho tshuaj ib hnub ib zaug Oral JAK1 inhibitors yog siv los kho cov neeg laus mob atopic dermatitis (AD) uas tsim nyog rau kev kho mob. Cibinqo yog ib tiam tshiab ntawm qhov ncauj JAK1 inhibitor tsim los ntawm Pfizer. Nws tau raug pom zoo hauv tebchaws United Kingdom thiab Nyij Pooj los kho cov tub ntxhais hluas thiab cov neeg laus uas muaj hnub nyoog qis rau AD hnub nyoog ≥12 xyoo.

Tsis tas li ntawd, CHMP kuj tau tshaj tawm qhov kev tshuaj xyuas zoo qhia tias qhov ncauj JAK inhibitor Xeljanz (tofacitinib) tau txais kev pom zoo rau qhov qhia tshiab: rau kev kho mob ntawm active ankylosing spondylitis (AS) cov neeg laus.

Xeljanz yog qhov ncauj JAK inhibitor. Nws tau raug pom zoo rau 4 qhov qhia hauv EU thiab yog qhov loj tshaj plaws ntawm tag nrho cov JAK inhibitors, suav nrog: (1) Cov neeg laus cov neeg mob uas muaj mob nruab nrab mus rau mob caj dab loj heev (RA); (2) Cov neeg laus uas muaj mob caj dab psoriatic (PsA); (3) Cov neeg laus uas muaj mob me me mus rau qhov mob hnyav heev (UC); (3) Active polyarticular juvenile idiopathic cov neeg mob hnub nyoog 2 xyoos thiab laus dua Cov neeg mob mob caj dab (pcJIA) thiab cov menyuam yaus PsA.

tofacitinibmechanism ntawm kev txiav txim: inhibition ntawm JAK (daim duab los ntawm cov ntaub ntawv PMID: 24883332)

Tam sim no, CHMP cov kev xav yuav raug xa mus rau European Commission (EC) rau kev tshuaj xyuas, uas xav tias yuav txiav txim siab zaum kawg ntawm kev tshuaj xyuasabrocitinibthiab Xeljanz daim ntawv thov los ntawm qhov kawg ntawm lub xyoo no. Yog tias EC tso cai rau kev lag luam hauv nruab nrab, nws yuav siv tau hauv txhua lub xeev EU cov tswv cuab, Iceland, Liechtenstein, thiab Norway.

Dr. Michael Corbo, Chief Development Officer of Inflammation and Immunology, Pfizer Global Product Development, tau hais tias: “Cov lus pom zoo ntawm CHMP coj peb los ze zog rau lub hom phiaj ntawm kev pab cov neeg mob uas muaj mob nruab nrab mus rau mob atopic dermatitis hauv Europe kom txo tau cov tsos mob. Peb tos ntsoov yuav ua haujlwm nrog European Commission. , Thiab cia siab tias yuav muab abrocitinib rau cov neeg mob European sai sai, thiab thaum kawg muab abrocitinib rau ntau pab pawg neeg raug kev txom nyem los ntawm tus kab mob no hauv ntiaj teb, ntau tus neeg tam sim no muaj kev xaiv kho mob tsawg."

Dr. Diamant Thaci ntawm Comprehensive Center for Inflamation Medicine ntawm University of Lubeck, Lub teb chaws Yelemees, tau hais tias: “Atopic dermatitis yog ib yam kab mob uas cuam tshuam rau lub neej niaj hnub ntawm ntau lab tus tib neeg. Piv nrog cov placebo,abrocitinibtau pom tias muaj txiaj ntsig zoo, suav nrog kev daws teeb meem Iconic chronic pruritus, tshem tawm cov kab mob ntawm daim tawv nqaij, kev txhim kho sai ntawm tus kab mob thiab qhov hnyav ntawm tus kab mob, thiab muaj txiaj ntsig zoo rau qhov profile. Yog tias pom zoo, abrocitinib muaj peev xwm los ua ib qho tseem ceeb hauv kev kho mob tshiab rau cov neeg mob uas muaj mob atopic dermatitis."

abrocitinib molecular qauv

Atopic dermatitis (AD) yog ib hom kab mob ntawm daim tawv nqaij ntev uas tshwm sim los ntawm daim tawv nqaij o thiab daim tawv nqaij tsis xws luag. Nws yog tus cwj pwm los ntawm daim tawv nqaij erythema, khaus, tawv / papule tsim, thiab exudation / scabbing. Tus kab mob no yog ib qho mob hnyav, tsis paub txog, thiab feem ntau ua rau muaj kab mob ntawm daim tawv nqaij uas yuav muaj kev cuam tshuam loj rau lub neej niaj hnub ntawm cov neeg mob thiab lawv tsev neeg. AD yog ib qho ntawm feem ntau, mob ntev thiab rov tshwm sim ntawm daim tawv nqaij thaum yau, cuam tshuam txog li 10% ntawm cov neeg laus thiab txog li 20% ntawm cov menyuam yaus thoob ntiaj teb. Ntau tus neeg mob nruab nrab mus rau qhov hnyav muaj kev tswj tsis tau zoo thiab xav tau kev kho mob ntxiv los daws cov tsos mob uas tseem ceeb tshaj plaws rau lawv.

Cov tshuaj nquag muaj ntawm Cibinqo yogabrocitinib, uas yog lub qhov ncauj me me molecule uas tuaj yeem xaiv inhibit Janus kinase 1 (JAK1). Inhibition ntawm JAK1 ntseeg tau tswj ntau yam cytokines koom nrog hauv cov txheej txheem pathophysiological ntawm atopic dermatitis (AD), suav nrog interleukin (IL)-4, IL-13, IL-31, IL-22 thiab thymic stromal lymphocyte ntau lawm Neeg tsis noj nqaij (TSLP). ).

Thaum lub Cuaj Hlis xyoo no, Cibinqo tau pom zoo hauv tebchaws United Kingdom thiab Nyij Pooj rau kev kho cov tub ntxhais hluas thiab cov neeg laus uas muaj mob hnyav rau mob atopic dermatitis (AD) uas tsim nyog rau kev kho mob, muaj cov lus teb tsis txaus rau cov kev kho mob uas twb muaj lawm, thiab muaj 12 xyoos thiab laus. Tam sim no, abrocitinib' daim ntawv teev npe tau xa mus rau ntau lub tebchaws thiab thaj chaw thoob ntiaj teb los tshuaj xyuas, suav nrog Tebchaws Meskas, Australia thiab European Union. Hauv Tebchaws Meskas, FDA tau tso cai rau abrocitinib Breakthrough Drug Designation (BTD) rau kev kho mob nruab nrab rau AD thaum Lub Ob Hlis 2018.

Hauv ntau qhov kev sim tshuaj,abrocitinibmuaj cov txiaj ntsig zoo hauv kev txo cov tsos mob thiab cov cim qhia ntawm AD, suav nrog txo cov tsos mob ntawm khaus sai thiab tshem tawm cov kab mob ntawm daim tawv nqaij. Hauv particular, nyob rau hauv lub taub hau-rau-lub taub hau Phase 3 JADE DARE (B7451050) txoj kev tshawb no, piv nrog subcutaneous txhaj tshuaj npaj Dupixent (Suav lub npe lag luam: Dabituo, generic lub npe: dupilumab), abrocitinib tau soj ntsuam nyob rau hauv txhua qhov kev ntsuam xyuas tag nrho cov curative nyhuv. cov cim qhia tau zoo tshaj plaws.