Tags : Upadacitinib

AbbVie Submits Regulatory Applications to the US FDA and EMA

Shots: The company submitted applications to the US FDA & EMA seeking approval for Rinvoq (upadacitinib) for adults (15mg/30mg, qd) and adolescents (15mg, qd) with moderate to severe AD. The submission is based on three pivotal P-III studies and was studied without TCS in Measure Up 1 and Measure Up 2 and with TCS in […]Read More

AbbVie Report Results of Rinvoq (upadacitinib) in a P-III AD

Shots: The P-III AD Up study involves assessing Rinvoq (15/30mg) + TCS vs PBO + TCS in patients (aged≥12) with the mod. to sev. AD who are candidates for systemic treatment. Patients receiving PBO + TCS were switched to either upadacitinib (15/30mg) + TCS @16wks. Results: @16wks. EASI 75 (65%/77% vs 26%); vIGA-AD 0/1 (40%/59% […]Read More

AbbVie Reports Results of Rinvoq (upadacitinib) as Monotherapy in a

Shots: The P-III Measure Up 2 study involves assessing of Rinvoq (15/30mg) vs PBO in adults and adolescents aged 12-18yrs. or older with mod. to sev. AD who are candidates for systemic treatment. Placebo patients were switched to either upadacitinib (15/30mg) @16wks. The study met its co-1EPs @16wks. i.e. improvement in EASI 75 (60%/73% vs […]Read More

AbbVie Reports Results of Rinvoq (upadacitinib) in P-III SELECT-PsA 2

Shots: The P-III SELECT-PsA 2 study involves assessing of Rinvoq (15/30mg) vs PBO in adult patients with active psoriatic arthritis who have responded inadequately to one or more biologic disease-modifying anti-rheumatic drugs (bDMARDs) The P-III SELECT-PsA 2 study results: @12wks. patients achieved ACR20 (57%/64% vs 24%), ACR 50(32%/38% vs 5%), ACR 70 (9%/17% vs 0.5%); […]Read More

AbbVie’s Rinvoq (Upadacitinib) Receives CHMP Positive Opinion to Treat Moderate

Shots: The CHMP positive opinion is based on P-III SELECT program including SELECT-NEXT, SELECT-BEYOND, SELECT-MONOTHERAPY, SELECT-COMPARE and SELECT-EARLY assessing Rinvoq in 4,400+ patients with mod. to sev. active RA In P-III studies, Rinvoq improved signs and symptoms of RA, inhibited radiographic progression and improved physical function, both as a monothx. and in combination with conventional […]Read More

AbbVie Reports Results of Upadacitinib in Two P-III Studies for

Shots: The P-III SELECT EARLY & SELECT-COMPARE study results involve assessing of Upadacitinib (15mg/30mg,qd) as monothx. & Upadacitinib + MTX (15mg, qd) vs MTX & adalimumab + MTX in patients with rheumatoid arthritis respectively The P-III SELECT EARLY & SELECT-COMPARE study results: @48wks. improvement in symptoms of rheumatoid arthritis measured by ACR20/50; maintain clinical remission […]Read More