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: Part A of P-lll study involves assessing of Dupixent (qw, 300mg) vs PBO in 81 patients aged≥ 12 yrs. with EoE. The study resulted in meeting its co-primary and all key 2EPs, presented at the virtual ACG 2020 and UEG Week 2020 Results: Patients reported significant improvement on DSQ as 4 wks. and continued […]Read More
Shots: The P-III LIBERTY ASTHMA VOYAGE study involves assessing of Dupixent (SC, 100/200mg, q2w ) + SOC maintenance therapy of medium-dose ICS with a second controller medication/ high-dose ICS with/out second controller medication vs PBO in 408 children 6 to <12 years old with uncontrolled moderate-severe asthma Results: Patients with baseline blood EOS ≥300 cells/μl […]Read More
Shots: The BT designation is based on Part A of P-III study assessing Dupixent (300mg) in 81 patients aged ≥12yrs. with EoE for 24wks. The Part A of P-III study met its co-1EPs and 2EPs i.e. reduction in symptoms, esophageal inflammation, abnormal endoscopic findings in the esophagus and has demonstrated safety results consistent with the […]Read More
Shots: The P-III OLE study involves assessing of Dupixent (300mg) + SOC in 2,282 adults/ adolescents with mod.-to-sev. asthma prior participated in a controlled Dupixent clinical trial, including the pivotal P-IIb DRI (24wks.) and P-III QUEST (52wks.) trials in patients with mod.-to-sev. asthma and the P-III VENTURE (24wks.) trial in patients with severe OCS-dependent asthma […]Read More
Shots: The Health Canada has approved a new indication as an add-on maintenance treatment with intranasal corticosteroids in patients with CRSwNP, inadequately controlled by systemic corticosteroids or surgery The approval is based on P-III studies (24wks. SINUS-24 and 52wks. SINUS-52) assessing Dupixent (300mg, q2w) + SOC intranasal corticosteroids vs PBO + intranasal corticosteroids. The studies […]Read More
Shots: The FDA approval is based on P-III study assessing Dupixent + TCS vs TCS as monothx. in children with severe AD. In the trial, children treated with Dupixent and TCS experienced improvements in overall disease severity, skin clearance and itch Results @16wks.: Dupixent (q4w & q2w) improvement in average EASI patients receiving (84% vs […]Read More
Shots: The P-IIIa Dupixent Eosinophilic Esophagitis study involves assessing Dupixent (N=42) (300mg weekly) v/s PBO (N=39) in 81 patients aged 12 years and older with eosinophilic esophagitis (EoE). In addition, enrolling patients for P-IIIb for extended active treatment period to continue in 28wks The P-II study results: met its co-1EPs and 2EPs in DSQ baseline […]Read More
Shots: The US FDA has accepted PR for Dupixent’s (dupilumab) sBLA as an add-on maintenance therapy for children aged 6-11yrs. with mod. to sev. AD not well controlled on topical prescription therapies The sBLA is based on data that includes P-III study assessing Dupixent + TCS vs TCS as monothx. in children with severe AD […]Read More
Shots: The EC has extended the marketing authorization of Dupixent (dupilumab) to include adolescents aged 12 to 17yrs. with mod. to sev. AD which is based on P-III LIBERTY AD program evaluating dupixent vs PBO The P-III LIBERTY program results: 75% improvement in disease extent, Skin improvement measured by EASI-75 (42% vs 8%); clear skin […]Read More
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