Category: dupilumab
Date: February 21, 2022 Issue #: 1644 Summary: Tezepelumab-ekko (Tezspire – AstraZeneca/Amgen), a subcutaneously administered thymic stromal lymphopoietin (TSLP) blocker, has been approved by the FDA for add-on maintenance treatment of severe asthma in patients ≥12 years old. It is the first TSLP blocker to become available in the US and the first biologic drug […]
Shots: The second P-III trial evaluates the efficacy and safety of Dupixent (300mg weekly) vs PBO in 240 patients aged ≥12yrs. with EoE for 24wks. The trial met its co-primary EPs i.e., reduction in disease symptoms from baseline (64% vs 41%); patients experienced a (23.78 vs 13.86 points) improvement on 0-84 DSQ scale & achieved […]
Shots: The P-III LIBERTY ASTHMA VOYAGE Trial evaluates Dupixent (100/200mg, q2w) + SoC in 408 children aged 6-11yrs. with uncontrolled mod. to sev. asthma The results showed a 65% avg. reduction in the rate of severe asthma attacks @1yrs.; improvement in lung function by 5.32% points @ 12wks. & as early as 2wks. & sustained […]
Shots: The NICE has issued a final appraisal determination (FAD) which recommends Dupixent (dupilumab) as an add-on maintenance treatment for severe asthma The NICE recommendation is based on a LIBERTY ASTHMA QUEST trial evaluating Dupixent vs PBO in patients with severe asthma with high exacerbation rates and high biomarkers indicating type 2 inflammation The results […]
Shots: The study A of P-III LIBERTY CUPID trial evaluates Dupixent vs SoC in 138 patients aged ≥6 yrs. with CSU who remained symptomatic despite antihistamine use and who were not previously treated with anti-IgE therapeutics The trial met its 1EPs & 2EPs @24wks. i.e. showed a reduction in itch severity (63% vs 35%), reduction […]
Shots: The P-III VOYAGE trial involves assessing Dupixent (100/200mg, q2w, based on weight) + SOC asthma therapy in 408 children aged 6-11yrs. with uncontrolled mod. to-sev. asthma with evidence of type 2 inflammation Results: improvement in asthma control @24wks. (1.34/ 1.33 vs 0.88/ 1.00); improvement in ACQ-7-IA; reduction in mean FeNO levels to below the […]
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 […]
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 […]
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 […]