Shots: The new analyses of the P-III BREEZE-AD5 trial and an extended safety analysis across multiple trials for Olumiant (2mg, qd) vs PBO in patients with AD showed improvements in the severity and extent of AD and patient outcomes, other key symptoms, and QoL as early as 1wks. Olumiant has also evaluated in patients with […]Read More
Shots: Health Canada has approved Dupixent for the treatment of mod. to sev. AD in children aged 6 to 11yrs. whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable The approval marks the fifth indication for Dupixent in Canada following the approvals for AD in adults and […]Read More
Shots: The P-I trial involves assessing MSB-0221 (ShA9) or vehicle applied topically on forearm skin in 54 adults with staphylococcus aureus-positive AD for 1week The expression of mRNA for psmα was inhibited from S. aureus isolated from all participants while the correlation was observed within 7days b/w improvement in local eczema severity and killing of […]Read More
Shots: The EC’s approval is based on a P-III study assessing Dupixent (300mg, q4w & 200mg, q2w) + TCS vas TCS alone in children aged 6-11yrs. with severe AD Result: improvement in disease extent and severity (82% & 80% vs 49% & 48%); at least 75% improvement (70% & 75% vs 17% & 26%); skin […]Read More
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
Shots: The company has enrolled the first patient in P-I/IIa Study assessing XZ.700 in 48 patients with mild to moderate AD in the Netherlands. This marks the world’s 1st evaluation of a pharmaceutical endolysin for topical use in humans The patients will be treated for 14 days with a cream containing XZ.700 at 3 different […]Read More
Shots: The positive opinion is based on P-III BREEZE-AD program including BREEZE-AD1 & BREEZE-AD2 studies assessing baricitinib as monothx. in mod. to sev. AD patients The CHMP’s recommendation also involves a BREEZE-AD4 study assessing baricitinib + topical corticosteroids in patients with mod. to sev. AD who have failed or who are intolerant to or have […]Read More
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
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
Shots: The BLA submission is based on P-III ECZTRA 1 & 2 studies assessing tralokinumab (300mg, SC) as monothx. vs PBO in 804 & 794 adults with mod. to sev. AD who were candidates for systemic therapy for 52wks. respectively The submission also follows the P-III ECZTRA 3 study assesses the safety and efficacy of […]Read More
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