US FDA tso cai saib xyuas qhov tseem ceeb rau JAK Inhibitor Opzelura Cream

If approved, ruxolitinib cream will be the first and only drug used to treat vitiligo for repigmentation. Vitiligo is a chronic autoimmune disease characterized by depigmentation of the skin, which is a skin disease caused by the loss of pigment-producing cells, melanocytes, which often affects beauty. Vitiligo affects about 0.5%-2.0% of the world's population. Currently, there is no drug therapy approved by the US FDA or EU EMA for the treatment of vitiligo. The disease can occur at any age, although many people with vitiligo will experience initial symptoms before the age of 20.

Ruxolitinib cream is Incyte's patented formulation of selective Janus kinase 1 and Janus kinase 2 (JAK1/JAK2) inhibitor ruxolitinib, designed for topical application. Incyte has global rights to develop and commercialize ruxolitinib cream. Currently, ruxolitinib cream is in phase 3 clinical development: (1) for the treatment of mild to moderate atopic dermatitis (TRuE-AD project); (2) for the treatment of vitiligo in adolescents and adults (TRuE-V project) .

In September 2021, the U.S. FDA approved Opzelura (ruxolitinib cream) for short-term and non-sustained chronic treatments. Receiving topical prescription therapies failed to adequately control the disease or when these therapies are undesirable and non-immune-compromised mild to moderate Atopic dermatitis (AD) adolescent (age ≥ 12 years) and adult patients.

Nws tsim nyog hais tias Opzelura yog thawj zaug thiab tsuas yog tshuaj pleev JAK inhibitor pom zoo los ntawm US FDA. Cov kev tshawb fawb tau pom tias txoj kev tsis zoo ntawm JAK-STAT txoj hauv kev ua rau cov yam ntxwv tseem ceeb ntawm AD, xws li khaus, khaus, thiab tawv nqaij tsis zoo. Hauv theem 3 kev tshawb fawb soj ntsuam, Opzelura kev kho mob txo cov tawv nqaij mob thiab khaus khaus cuam tshuam nrog AD. Thiab txo qhov khaus tuaj yeem txhim kho cov kab mob tseem ceeb thiab kev ua neej zoo rau cov neeg mob AD.

The regulatory application of ruxolitinib cream for the treatment of vitiligo is based on the results of the key Phase 3 TRuE-V clinical trial project. The data showed that the two phase 3 clinical studies of the project reached the primary and key secondary endpoints: after 24 weeks of treatment, compared with the excipient cream treatment group, the facial and whole body skin lesions in the ruxolitinib cream treatment group were restored The color has improved significantly. In this project, no clinically significant site reactions were reported for ruxolitinib cream for 24 weeks, and the overall safety is good.

Jonathan Dickinson, Tus Lwm Thawj Coj Tus Lwm Thawj Coj thiab European General Manager ntawm Incyte, tau hais tias:" EMA' qhov kev lees txais ntawm ruxolitinib cream MAA yog ib qho tseem ceeb rau cov pab pawg neeg mob vitiligo. Rau lawv, lawv lub neej niaj hnub feem ntau cuam tshuam, thiab kev kho mob tam sim no txwv. . Peb tau cog lus los mloog cov kev xav ntawm cov neeg mob hauv zej zog kom nkag siab tias peb tuaj yeem pab tau raws li qhov xav tau thiab txhawb nqa cov kws kho mob kom tswj tau tus kab mob nyuaj no zoo dua. Peb tos ntsoov yuav ua haujlwm nrog cov koom haum tswj hwm los txhim kho Txoj kev kho tshiab no coj cov neeg mob tsim nyog."

Ruxolitinib yog cov khoom siv tshuaj nquag ntawm Incyte' lub qhov ncauj tshuaj Jakafi. Cov tshuaj tau pom zoo rau 3 qhov kev qhia hauv Tebchaws Meskas: (1) Kev kho mob ntawm cov neeg laus cov neeg mob polycythemia (PV) uas muaj cov lus teb tsis txaus lossis tsis txaus siab rau sulfhydryluria; (2) Kev kho mob ntawm cov neeg laus nruab nrab thiab muaj kev pheej hmoo siab mob myelofibrosis (MF), suav nrog thawj MF, post-PV MF, post-tseem ceeb thrombocythemia MF; (3) Kev kho mob ntawm steroid-refractory acute graft-tiv thaiv-tus kab mob (GVHD) cov neeg mob. Ntawm lawv, qhov kev qhia thib peb tau pom zoo los ntawm FDA thaum lub Tsib Hlis 2019, thiab nws yog thawj cov tshuaj pom zoo rau kev kho mob ntawm qhov ntsuas no. Jakafi yog muag los ntawm Incyte hauv Tebchaws Meskas, thiab Novartis yog muag raws li Jakavi hom npe hauv khw sab nraum Tebchaws Meskas.

Tam sim no, Kev hais kwv txhiaj tseem tab tom txhim kho ruxolitinib molecule hloov nrog deuterium tshuaj technology-CTP-543. Hauv kev tshawb fawb theem II, nws tau pom tias muaj kev ua tau zoo hauv kev kho mob ntawm alopecia areata. Alopecia areata yog ib hom kab mob autoimmune uas ua rau cov plaub hau poob ib nrab los yog ua tiav. Kev hloov kho tshuaj deuterium ntawm ruxolitinib tuaj yeem hloov pauv nws cov tib neeg cov tshuaj pharmacokinetics, yog li txhim kho nws siv raws li kev kho mob rau alopecia areata. Hauv Tebchaws Meskas, FDA tau tso cai CTP-543 nrawm nrawm rau kev kho mob alopecia areata.