Faomhann US FDA tásc nua d'inhibitor JAK1 Rinvoq: cóireáil othar fásta agus ógánach!

D’fhógair AbbVie inniu go bhfuil Rinvoq (FDA) ceadaithe ag Riarachán Bia agus Drugaí na SA (FDA).suasdacitinib) for the treatment of children ≥12 years of age with refractory moderate-to-severe atopic dermatitis (AD) and adult patients. This medicine is specifically indicated for: adults and children with moderate to severe AD who have not responded to prior therapy and who are not well controlled with other oral medications or injectables (including biologics), or who are not recommended for other oral medications or injectables ( ≥12 years old) patients. In terms of medication, Rinvoq 15mg, once daily, can be used for adults weighing ≥ 40 kg and children 12 years and older. In adults and children under 65 years of age who have not achieved an adequate response, the dose may be increased to 30 mg once daily.

Is coscaire JAK ó bhéal, uair sa lá, roghnach, inchúlaithe é Rinvoq atá formheasta san AE le haghaidh 4 thásc (airtríteas réamatóideach [RA], airtríteas psoriatic [PsA], spondylitis tonic [AS], dheirmitíteas atópach [AD]), 3 thásca ( RA, PSA) ceadaithe sna Stáit Aontaithe. Tá dáileog Rinvoq 15mg oiriúnach chun na tásca thuas go léir a chóireáil, agus níl Rinvoq 30mg oiriúnach ach amháin le haghaidh cóireáil AD.

AD Sonraí Tionscadal Clárúcháin Chéim 3 Dhomhanda

The AD indication approval is based on data support from one of the largest AD global Phase 3 registration projects. The program includes 3 global pivotal studies (Measure Up 1, Measure Up 2, AD Up) enrolling more than 2500 patients with moderate-to-severe atopic dermatitis (AD) evaluating Rinvoq as monotherapy (Measure Up 2, AD Up). Efficacy and safety of Up 1, Measure Up 2) and combined topical corticosteroids (AD Up) versus placebo. Across all 3 studies, the co-primary endpoint was at least a 75% improvement in the Eczema Area and Severity Index (EASI75) and a Validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD) score of 0 at week 16 of treatment /1 (complete or almost complete clearance of the lesion).

Léirigh na torthaí gur chomhlíon an dá dháileog de Rinvoq na críochphointí bunscoile agus tánaisteacha go léir i staidéir Chéim 3 go léir: i gcomparáid le phlaicéabó, othair sa ghrúpa Rinvoq-cóireáilte ag seachtaine 16 agus pointí ama eile (p<0.001) bhí="" feabhas="" tapa="" agus="" suntasach="" ar="" imréiteach="" loit="" agus="">

Is é Rinvoq's comhábhar gníomhach cógaisíochta, coscaire JAK1 ó bhéal roghnach agus inchúlaithe a d'aimsigh agus a d'fhorbair AbbVie atá á fhorbairt chun cóireáil a dhéanamh ar roinnt galair athlastacha trí mheán imdhíonachta. Is kinase é JAK1 a bhfuil ról lárnach aige i bpaitifiseolaíocht galair athlastacha éagsúla.